Reproductive Surgery in the Era of ART (Didactic)

PROGRAM CHAIR William W. Hurd, MD

G. David Adamson, MD Victor Gomel, MD Keith B. Isaacson, MD

Sponsored by AAGL Advancing Minimally Invasive Gynecology Worldwide

Professional Education Information

Target Audience Educational activities are developed to meet the needs of surgical gynecologists in practice and in training, as well as, other allied healthcare professionals in the field of gynecology.

Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The AAGL designates this live activity for a maximum of 3.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ...... 1

Disclosure ...... 3

Tubal Reconstructive Surgery vs. ART V. Gomel ...... 5

Hydrosalpinx and Other Indications for Laparoscopy for the Infertile Patient G.D. Adamson ...... 16

When and How to Evaluate the Uterine Cavity: HSG vs. Sonohysterography vs Office Hysteroscopy K.B. Isaacson ...... 23

When and How to Removal Intramural Fibroids to Improve Fertility W.W. Hurd ...... 32

Tubal Ligation Reversal vs. IVF V. Gomel ...... 39

Ovarian Surgery: Endometriomas and Ovarian Drilling W.W. Hurd ...... 47

Surgical Treatment of Uterine Anomalies: Indications and Techniques K.B. Isaacson ...... 53

Does Treating Endometriosis Improve infertility? G.D. Adamson ...... 58

Cultural and Linguistics Competency ...... 65

PG 216 Reproductive Surgery in the Era of ART (Didactic)

William W. Hurd, Chair Faculty: G. David Adamson, Victor Gomel, Keith B. Isaacson

Course Description

The development of Assisted Reproductive Technologies (ART), particularly in vitro fertilization (IVF), has dramatically changed the surgical approach to the infertile patient. At the same time, advances in minimally invasive surgery have allowed a broad range of pelvic procedures to be performed as outpatient surgery or in the office. As a result, surgical indications and approaches continue to evolve based on new information about the effects of pelvic pathology on infertility and new surgical and non- surgical technology. This course is a candid discussion by four reproductive surgeons who specialize in infertility about the important and shifting roles of reproductive surgery in the era of ART and IVF. The course will describe the most recent advances and recommendations for the diagnosis and surgical treatment of common causes of infertility, including endometriosis, hydrosalpinx, fibroids, pelvic adhesions, tubal occlusion, intra-uterine pathology and polycystic ovary syndrome.

Course Objectives

At the conclusion of this course, the participant will be able to: 1) List the fertility effects of common gynecologic conditions, including leiomyoma, hydrosalpinx, endometriosis and uterine septum; 2) evaluate the relative merits of the different methods for detecting intrauterine pathology in the infertile patient; 3) compare the advantages and disadvantages of the various surgical methods for diagnosing and treating endometriosis in infertile women; 4) demonstrate knowledge of when and how best to remove intramural fibroids in the infertile patient; and 5) distinguish and compare various surgical methods for treating hydrosapinx in infertile women.

Course Outline

1:30 Welcome, Introductions and Course Overview W.W. Hurd

1:35 Tubal Reconstructive Surgery vs. ART V. Gomel

2:00 Hydrosalpinx and Other Indications for Laparoscopy for the Infertile Patient G.D. Adamson

2:25 When and How to Evaluate the Uterine Cavity: HSG vs. Sonohysterography vs Office Hysteroscopy K.B. Isaacson

2:50 When and How to Removal Intramural Fibroids to Improve Fertility W.W. Hurd

3:15 Questions & Answers All Faculty

3:25 Break

3:40 Tubal Ligation Reversal vs. IVF V. Gomel

1

4:05 Ovarian Surgery: Endometriomas and Ovarian Drilling W.W. Hurd

4:30 Surgical Treatment of Uterine Anomalies: Indications and Techniques K.B. Isaacson

4:55 Does Treating Endometriosis Improve infertility? G.D. Adamson

5:20 Questions & Answers All Faculty

5:30 Course Evaluation

2 PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* Jonathan Solnik Other: Lecturer - Olympus, Lecturer - Karl Storz Endoscopy-America

SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: CooperSurgical, Ethicon Women's Health & Urology, Intuitve Surgical Other: Royalties - CooperSurgical Linda Bradley Grants/Research Support: Elsevier Consultant: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharmaceuticals Speaker's Bureau: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharm Keith Isaacson Consultant: Karl Storz Endoscopy Rosanne M. Kho Other: Honorarium - Ethicon Endo-Surgery C.Y. Liu* Javier Magrina* Ceana H. Nezhat Consultant: Intuitve Surgical, Lumenis, Karl Storz Endoscopy-America Speaker's Bureau: Conceptus Incorporated, Ethicon Women's Health & Urology William H. Parker Grants/Research Support: Ethicon Women's Health & Urology Consultant: Ethicon Women's Health & Urology Craig J. Sobolewski Consultant: Covidien, CareFusion, TransEnterix Stock Shareholder: TransEnterix Speaker's Bureau: Covidien, Abbott Laboratories Other: Proctor - Intuitve Surgical

FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). William W. Hurd* G. David Adamson Consultant: LabCorp Other: CEO and Founder - Advanced Reproductive Care Victor Gomel* Keith B. Isaacson

3 Consultant: Karl Storz Endoscopy Joseph S. Sanfilippo*

Asterisk (*) denotes no financial relationships to disclose.

4 DISCLOSURE TUBAL • RECOSTRUCTIVE SURGERY I have no financial relationships to disclose. VERSUS ART

Professor Victor Gomel

Victor Gomel

REPRODUCT. SURGERY- • The presence of a credible alternative DEVELOPMENTS with IVF, permits to operate in cases with better prognosis and obtain • Microsurgery better results. • Surgical access by laparoscopy

• Most cases can be done byyp laparoscopy • Surgical access by minilaparotomy as part of initial diagnostic procedure. • Hysteroscopic surgical access • Complex cases may require use of a minilap, performed on day care basis. • Prevention of postoperative adhesions

Gomel V. Reproductive Surgery in Reconstructive & Reproductive Surgery, Informa, London 2010

Victor Gomel Victor Gomel

ART- USA: 2000- 2009 SURGERY VERSUS IVF

SURGERY*

COMMERCIALIZATION OF IVF SERVICES IVF

*Both practice and teaching of surgery Victor Gomel Victor Gomel

5 NO. EMBRYO TRANSFERRED- USA ASSISTED REPRODUCTION- USA 2008 2008 DAY 33 DAY 5 1.7%1.7% 4.6%4.6%

19.2%19.2% 1515..55%% 13.0%13.0% 9.7%9.7% 34.0%34.0%

. Singletons 64.3%64.3% 31.1%31.1%40.0%40.0% 67.0%67.0% . Twins . Triplets +

13,892 Live Births

CDC Reproductive Health; www.cdc.gov/art/ART 2008 CDC Reproductive Health; www.cdc.gov/art/ART 2008

Victor Gomel Victor Gomel

ART- EUROPE: 2008 IMPACT OF MULTIPLE BIRTHS Delivery/OPU IVF ICSI Multi preg • Increased obstetrical complications Europe 21.1 20.2 22.3 • Increased neonatal complications/ deaths France 19.2 20.5 19.3 Germany 16.0 16.1 21.8 • Responsible for major societal costs

Itay 15.2 14.3 23.4 • Significant financial burden and emotional U. Kingdom 26.4 27.5 17.9 costs for the parents.

de Mouzon et al. Hum Reprod. 201; 27: 954‐ 966

Victor Gomel Victor Gomel

FIRST IVF BABY IVF AS PRIMARY TREATMENT MADE IN CANADA • Male factor infertility

• Age of female partner

• Tubal disease + Male factor

• Inoperable tubal disease

• Others: ie. need for PGD Born December 25, 1983 Gomel V. Reproductive Surgery in Reconstructive & Reproductive Surgery, Informa, London 2010

Victor Gomel Victor Gomel

6 INFERTILITY- INVESTIGATION

• Clinical assessment* HSG • Semen analysis

• Assessment of ovulation PHIMOSIS • Assess tubal factors- HSG

HYDROSALPINX * Sonography is part of clinical assessment Le Toucher, in Maygrier JP. Paris,1822 Victor Gomel Victor Gomel

INFERTILITY- INVESTIGATION

• HSG Clinical assessment* • Semen analysis

• Assessment of ovulation

• Assess tubal factors- HSG

HYDROSALPINX • Laparoscopy ± hysterocopy

* Sonography is part of clinical assessment Le Toucher, in Maygrier JP. Paris,1822 Victor Gomel Victor Gomel

DISTAL TUBAL

DISEASE

LAPAROSCOPY

Victor Gomel Victor Gomel

7 LAPAROSCOPY LAPAROSCOPY

SALPINGO- OVARIOLYSIS SALPINGO- OVARIOLYSIS

Victor Gomel Victor Gomel

SALPINGO- SALPINGOSTOMY OVARIOLYSIS

LIVE BIRTH RATE >50% LIVE BIRTH RATE ±30%

Gomel V, McComb PF. J Reprod Med. 2006; 51: 177‐84. Victor Gomel Victor Gomel

SALPINGOSTOMY BY MICROSURGERY

AFS Score* Patients # Pregn. %

Mild ¤ 17 12 71

Severe 73 15 21

Total 90 27 30

* AFS Classification Gomel V., Erenus M.; 1990 ¤ p < 0.05 Victor Gomel Victor Gomel

8 INFLUENCE OF SALPINGOSTOMY FOR HYDROSALPINX ON IVF OUTCOMES

p=0.019p=0.019

p=0.040p=0.040 ** p=0.057p=0.057

“The evidence is fair to recommend laparos- rates p=0.083p=0.083 y copic fimbrioplasty and neosalpingostomy for ** the treatment of mild hydrosalpinges in young Deliver women with no other significant infertility factors.”

n=185n=185n=97 n=75n=75 n=39n=39 Fertil Steril. 2012; 97: 539‐ 459

Victor Gomel Strandel A. et al. Hum Reprod. 2001; 16: 2403-10

SALPINGOSTOMY FOR HYDRO BEFORE IVF ASRM GR I GR II GR III GR IV PRACTICE

COMMITTEE IMP/ET 2.8% 18.8% 16.7% 27.3%

PR/ET 8.5% 39.0% 43.0% 60.0%

GROUP I: Hydrosalpinx untreated GROUP II: Salpingectomy GROUP III: Salpingostomy GROUP IV: Proximal tubal occlusion Fertil Steril. 2008; 90: S66-8 Murray DL. et al. Fertil Steril. 1998; 69: 41‐5 Victor Gomel

TUBO-TUBAL ANASTOMOSIS

REVERSAL OF STERILIZATION

Victor Gomel Victor Gomel

9 TUBO-CORNUAL HSG ANASTOMOSIS

PROXIMAL TUBAL DISEASE PROXIMAL TUBAL DISEASE

Victor Gomel Victor Gomel

HSG SELECTIVE CORNUAL SALPINGOGRAPHY OCCLUSION

SELECTIVE SALPINGOGRAPHY

Victor Gomel Victor Gomel

HSG TUBO-CORNUAL ANASTOMOSIS TUBAL CANNULATION

Victor Gomel Victor Gomel

10 Excision of diseased isthmic segment

Placement of the first anastomotic suture

Victor Gomel Victor Gomel

MINI-LAPAROTOMY TUBO-CORNUAL ANASTOMOSIS LIVE BIRTH RATE ± 50%

Musculo-epithelial layer approximted

Gomel V. Fertil Steril. 1997; 28: 59- 67 Victor Gomel

MINI-LAPAROTOMY PROTRACTOR® Combines functions of wound protector and retractor

11 TUBO-CORNUAL ANASTOMOSIS*

Patients (n=48) No. %

∞ Spontaneous abortion 3 “Unless the proximal blockage on HSG is clearly due to SIN, selective salpingography or tubal Ectopic pregnancy 3° 6.2% cannulation can be attempted d”.”

Viable birth 27 56.2% “Before performing this procedure , there should be confirmation of normal distal tubal anatomy.” * For proximal disease, by microsurgery. ∞ Two of these patients had viable births as well. ° One of these patients had a viable birth as well.

Gomel V. Microsurgery in Female Infertility. Little Brown. Boston. 1983

Victor Gomel Fertil Steril. 2012; 97: 539‐ 459 Victor Gomel

UNUSUAL

“... IVF is preferred to resection and microsurgical MICROSURGICAL anastomosis.” PROCEDURES “… microsurgery may be considered after failed tubal cannulation if IVF is not an option for the patient, but it should be only by those with appropriate training.”

Fertil Steril. 2012; 97: 539‐ 459 Victor Gomel Victor Gomel

Ovary and occluded ampullary stump

Mobilization of adnexa with its vascular pedicle

Gomel V. Fertil Steril 1985; 43: 804‐ 8 Victor Gomel Victor Gomel

12 Intramural segment

Victor Gomel Gomel V. Fertil Steril 1985; 43: 804‐ 8 Victor Gomel

Ampullary stump

Ampullary-intramural anastomosis

Victor Gomel Victor Gomel

REPRODUCTIVE SURGERY Successful surgery offers the couple multiple cycles in which to achieve conceppytion naturally,, and the opportunity to have more than one pregnancy after a single surgical intervention.

Gomel V. Fertil Steril 1985; 43: 804‐ 8 Victor Gomel Victor Gomel

13 RATE OF BIRTHS USA 2001 -9 IVF: TREATMENT CYCLES Several studies have shown conclusively Delivery/cycle initiated 28.5 % that the majority of couples undergoing IVF-ET Delivery/ 3 cycles initiated 54.0? % do not whish to complete 3 cycles of IVF.

> 50% of IVF Cycles were ICSI cycles. Land JA, Coultar DA, Evers JL. Fertil Steril. 1997; 68: 278-81 CDC Reproductive Health; www.cdc.gov/art/ART 2009 Olivius K et al. Fertil Steril. 2002; 77: 505-10 Frydman R. Convictions 2010. Bayard ; Paris

Victor Gomel Victor Gomel

THE WAY IN WHICH ENDOMETRIOSIS* ‐ IVF HUMAN LIFE NORMALLY BEGINS… Cumulative III+IV Endo I+II Tubal Pregnancy° (n=67) (n=31) (n=87)

Fresh Embryo % Not22.6 successful40.0 36.6 Fresh + Frozen % 56.7 >50%67.7 81.6

Fre + Fro Birth % 40.3 55.8 43.7

* Endometriosis associated infertility; 98 consecutive women treated with IVF or ICSI ° Cumulative pregnancy after 1‐ 4 cycles of IVF/ICSI treatment. . Kuivasaari P et al. Human Reprod. 2005

Victor Gomel Victor Gomel

TUBO-CORNUAL ANASTOMOSIS- RESULTS

Outcome no. Patients %

Total patients 59 Viable births 27 45.8% Of 32 with no births 21 treated 66 ē cycles IVF Viable births 12 Viable births total 39/ 59 66.1%

Tomazevic T et al. Hum Reprod 1996; 11: 2613

Victor Gomel Victor Gomel

14 “The assimilation of microsurgical • Reproductive surgery has a significant techniques and principles into our specialty role in infertility. made the gynecologist much more • The cost of IVF is prohibitive for many. conscious of avoiding peritoneal trauma and more careffgul in tissue handling and tissue • Refuse IVF for religious/ethical reasons. care. It made the gynecologist more • ±50% fail to obtain a baby with IVF. conscious of conservation, • A percentage need surgery before IVF and overall a better surgeon.” for myomas, adnexal tumors, endometriosis, etc.

Gomel V. Fertil Steril. 1983; 39: 144‐ 156

Victor Gomel Victor Gomel

•Training in reproductive surgery is essential THANK YOU - to improve IVF outcome MERCI - to ensure gynecologists remain GRACIAS refined surgeons ありがとう OBRIGADO • Surgery and ART are complementary. TEŞEKÜRLER • Selection of treatment should be based on GRAZZIE the clinical findings and the circumstances EYXAPIΣТΩ ٙشكرا .of each couple

Gomel V. Minerva Gynecol. 2005; 57: 21‐ 8

Victor Gomel Victor Gomel

TRANSPOSITION OF TUBE & OVARY

Gomel V. Fertil Steril 1985; 43: 804‐ 8 Victor Gomel Victor Gomel

15 Hydrosalpinx and Other Indications for Laparoscopy Disclosures in the Infertile Patient • Grants/Research Support: Auxogyn, Bayer‐Sherring, EMD‐ Serono • Consultant: LabCorp Las Vegas, NV • Other: CEO and Founder ‐ Advanced Reproductive Care Tuesday, November 6, 2012

David Adamson, MD Director, Fertility Physicians of Northern California Clinical Professor, Stanford University Associate Clinical Professor, UCSF

Objectives

• List the indications and contraindications for performing salpingectomy in an infertile patient. Patient • Describe pathological pelvic anatomical conditions that are potentially mitigated by surgery. Selection • Compare the relative advantages and disadvantages of laparoscopy vs. ART in the infertile patient.

Clinical Application of Laparoscopy Factors That Will Affect the • Younger women (?<37 years of age) Choice of Treatment • Short duration of infertility (<4 years) • Prior pregnancy • Family • Desire for diagnosis • Normal male factor – Current socioeconomic • Perspective on use of • Normal or treatable uterus status technology for • Normal ovarian reserve and – Current size reproduction • Normal ovultilation or easily ttbltreatable ovultilation disor der – Future plans • Limited prior treatment • Perspective on risks – Time frame • Appropriate candidate for laparoscopy – Surgery – “Treatable” disease reasonably suspected (NNT) • Treatment – Multiple pregnancy – No contraindications/risks for laparoscopy, pregnancy – Financial resources – • Religious beliefs Patient accepts 9 to 15 months interval to IVF – Insurance coverage

16 Phimosis and Hydrosalpinx

ASRM Practice Guidelines, 2001. ASRM Practice Guidelines.

Surgery for Distal Tubal Disease— Good Prognosis • Hydrosalpinges and fimbrial phimosis • PID, Peritonitis, Prior surgery • Good prognosis – Liitdimited filmy adldnexal adhes ions – Mildly dilated tubes (<3 cm) with thin, pliable walls – Lush endosalpinx with preservation of the mucosal folds (1)

(1) American Fertility Society. Fertil Steril 1988;49:944–55.

17 Surgery for Distal Tubal Disease— Fimbrioplasty and Good Prognosis Neosalpingostomy • Intrinsically normal tubes • Pregnancy rates depend – Peritubal adhesions – Degree of tubal disease – More favorable with good‐prognosis patients (1,2) – Endometriosis • Hyypgdrosalpinges (()1) Mild Severe – May mechanically impair oocyte capture – IUP 58‐77% 0‐22% • Treatment outcomes – Ectopic 2% to 8% 0‐17% – Laparotomy adhesiolysis at 12 months 40% • Irreversible deciliation – Untreated 8% (1) (1) Nackley. Fertil Steril 1998;69:373–84. (1) Tulandi Am J Obstet Gynecol 1990;162:354–7. (2) Milingos. J Am Assoc Gynecol Laparosc 2000;7:355–61.

Fimbrioplasty and Surgical Treatment of Neosalpingostomy Hydrosalpinges and IVF • Fimbrioplasty similar to neosalpingostomy • Hydrosalpinges • Perform laparoscopically; results same, risk less (1,2) – Blocked tube at end secretes fluid faster than it is • IVF preferred over neosalpingostomy reabsorbed – Older women, male factor, other factors – Salpingostomy may improve IVF success and allow spontaneous conception – Becomes enlarged sac of secretions – Tuboplasty is not appropriate for severe or both proximal & distal obstruction • Inflammatory/toxic fluid leaks back into uterus – Consented both salpingostomy and salpingectomy – Direct mechanical flushing effect on embryo(s) • Postoperative reocclusion may occur, necessitating more surgery – Direct embryotoxic effect (1) ASRM Practice Committee. Fertil Steril 2006;86:S264–7. – Effect on endometrial receptivity

(2)Bontis. Ann NY Acad Sci 2006;1092:199–210. ASRM Practice Committee. Fertil Steril 2008;90:S66–8.

Does Hydrosalpinx Affect Hydrosalpinges and IVF IVF‐ET Outcome? Cochrane Meta‐Analysis • Retrospective analysis • 14 different studies of IVF • Hydrosalpinx with US evidence of dilated tubes – 60 patients had 116 initiated cycles and 106 ET • 5592 women • Tubal Factor Controls – – 940 patients had 1428 initiated cycles and 1150 ET 1004 unilateral or bilateral hydrosalpinges • Outcomes – 4884588 tublbal bloc kage no hdhydrosa lilpinx – Implantation 16% vs. 21% (P = 0.013) – – Preclinical Loss 37% vs. 14% (P=0.001) 8703 IVF embryo transfers – Miscarriage 25% vs. 20% (P=0.28) Camus. Hum. Reprod 1999;14 (5):1243‐9. – Ectopic 8% vs. 3% (P=0.04) – Delivery/ET 26% vs. 34% (P=0.066) Barmat. JARG 1999;16(7):350-4.

18 Effect of Hydrosalpinges on Effect of Hydrosalpinges on IVF Outcomes IVF Outcomes • 2 Meta‐analyses • PR 19.7% vs. 31.2% (OR=0.64; 95% CI 0.56, 0.74). – 6700 cycles in 11 studies & 4 abstracts • IR 8.5% vs. 13.7% • Pregnancy Rate • SAB (miscarriage) 43.7% vs. 31.1% (OR 0.58; 95% CI, – Tubal infertility PR 31.2% 0490.49–0.69) – Hydrosalpinges PR 16.4% • PR 49% lower – Fresh and FET • Delivery rate 13.4% vs. 23.4% • Miscarriage – 2.3‐fold (95% CI, 1.6–3.5) Zeyneloglu. Fertil Steril 1998;70:492–932. Camus. Hum Reprod 1999;14 (5):1243‐9. Camus. Hum Reprod 1999;14:1243–9.

Impact of Ultrasound Appearance Indications for Salpingectomy or of Hydrosalpinges Tubal Occlusion • Hydrosalpinx is Ultrasound‐visible • Indication – Implantation and Ongoing Implantation – Fallopian tube is damaged beyond repair by • OR=0.33‐0.46, C.I. 0.21‐0.96 infection, endometriosis, or ectopic pregnancy – Cumulative chance ongggoing ppgregnanc y after 1+ cycles • Poor ppgrognosis • Relative hazard 0.36, C.I. 0.22‐0.59 – Extensive, dense peritubal adhesions • Hydrosalpinx not visible by ultrasound – Massively dilated tubes – IVF outcome not reduced – Thick fibrotic walls, and/or

Strandell. Hum Reprod 1999;14:2762–9. de Wit.Hum Reprod 1998;13:1696–701. – Sparse or absent luminal mucosa ASRM Practice Cmttee. Fertil Steril 2012 Mar;97(3):539-45.

Effect of Treating Hydrosalpinges Does Treatment + IVF Work? Before IVF • 3 RCT • Pilot study of 90 – Hydro or SIN – LS and treatment vs LS look only – PR per cycle 23.7% tx vs 16.3% none • 204 patients with hydrosalpinges tx vs no – delivery rate 28.6% vs 16.3% (P=.045) – If seen on U/S 40.0% vs 17.5% (P=.038)

Strandell, Hum. Reprod 1999;14 (11):2762‐9. ASRM Practice Committee. Fertil Steril 2012;97:539–45.

19 Surgical Treatment for Tubal Disease in Surgical Treatment for Tubal Disease in Women Due to Undergo IVF (1) Women Due to Undergo IVF (2) • Laparoscopic occlusion vs. no intervention • 5 RCT comparing surgical treatment vs. control group – Ongoing Pregnancy: Peto OR 7.24, 95%CI 0.87 to 59.57 – N=646 – Clinical Pregnancy: Peto OR 4.66, 95%CI 2.47 to 10.01 – Salpingectomy vs. No Treatment, 4 trials • Tubal occlusion to salpingectomy – Salpingectomy vs. Tubal occlusion, 2 trials – Ongoing Pregnancy: Peto OR: 1.65, 95%CI 0.74, 3.71 – Aspiration vs. No Treatment, 1 trial – Clinical Pregnancy: Peto OR 1128.28, 95%CI 0760,76 to 2142.14 • Outcomes Laparoscopic Salpingectomy • US‐guided aspiration (1 RCT) – Ongoing Pregnancy: Peto OR 2.14, 95%CI 1.23 to 3.73 – Clinical Pregnancy: Peto OR 1.97, 95%CI 0.62 to 6.29 – Clinical pregnancy: Peto OR 2.31, 95%CI 1.48 to 3.62 • No significant differences in adverse effects of surgical treatments

Johnson. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD002125. Johnson. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD002125.

Proximal Tubal Occlusion by Aspiration and Neosalpingostomy Hysteroscopic Approach Before IVF • Essure coil inserts • Ultrasound‐guided aspiration of hydrosalpinges at the time of oocyte – Data on IVF success rates are limited to a few very small case series (1,2). retrieval yielded conflicting results in two small retrospective studies (1,2) – ? Trailing coils have potential to act as an IUD intrauterine • A randomized study comparing ultrasound‐guided aspiration with a – Complete tissue encapsulation coils 17% of patients within 1 year & 25% nontreated control reported significantly higher clinical pregnancy rates at 13–43 months (3). with aspiration (3). • Adiana: no data • Intuitively, it makes sense that laparoscopic neosalpingostomy before IVF should improve the pregnancy rate, but there are still no confirmatory – Radiofrequency energy to stimulate interstitial scarring followed by studies. insertion of a small silicone elastomer matrix

(1) Mijatovic. Fertil Steril 2010;93:1338–42. (1) Sowter. Hum Reprod 1997;12:2147–50. (2) Darwish. Acta Obstet Gynecol Scand 2007;86:1484–9. (2) Van Voorhis. Hum Reprod 1998;13:736‐9. (3) Kerin. J Min Invas Gynecol 2007;14:202–4. (3) Hammadieh. Hum Reprod 2008;23:1113–17.

Conclusions: Surgical Treatment for Tubal Effect of Unilateral Hydrosalpinges Disease in Women Due to Undergo IVF (3) on IVF Pregnancy Rates • Surgical treatment should be considered for all women with hydrosalpinges prior to IVF treatment. • Even patients with a unilateral hydrosalpinx have been shown to have lower pregnancy rates with IVF (1,2) • Laparoscopic tubal occlusion is an alternative to • Unilateral salpingectomy resulted in a significant laparoscopic salpingectomy in improving IVF PR. improvement in IVF pregnancy rates in these patients (3) • FhFurther research is requidired to assess the val ue of • Salpingectomies for bilateral hydrosalpinges yielded higher aspiration of hydrosalpinges prior to or during IVF IVF pregnancy rates than for unilateral hydrosalpinges (4) procedures and also the value of tubal restorative (1) Kassabji. Eur J Obstet Gynecol Reprod Biol 1994;56:129–32. surgery as an alternative (or as a preliminary) to IVF. (2) Murray. Fertil Steril 1998;69:41–5. (3) Shelton. Hum Reprod 1996;11:523–5. Johnson. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD002125. (4) Strandell. Hum Reprod 1999;14:2762–9.

20 Chances for Pregnancy After Technical Aspects of Salpingectomy Unilateral Salpingectomy • Coagulate and divide tube close to cornua • 25 women with one hydrosalpinx • Serially coagulate and cut the mesosalpinx – 18 salpingectomy or 7 tubal ligation • Stay close to the tube to avoid – ppgregnanc y rates naturally without IVF • 88% women achieved pregnancy – thermal injury to the ovary – Salpingectomy quicker – Vascular injury of ovarian blood supply • Mean time to pregnancy 5.6 months • Ovarian injury possible but avoidable (1‐3) (1) Chan. Hum Reprod 2003;18:2175–80. Sagoskin. Hum Rerod 2003 Dec;18(12):2634‐7. (2) Dar. Hum Reprod 2000;15:142–4. (3) Strandell. Hum Reprod 2001;16:1135–9.

Summary and Conclusions 1. The live birth rate achieved with IVF among women with hydrosalpinges is approximately one half that observed in women without hydrosalpinges. 2. In women with hydrosalpinges, preliminary laparoscopic salpingectomy or proximal tubal occlusion improves subsequent pregnancy and live birth rates achieved with IVF. For every six women with hydrosalpinges, one more ongoing pregnancy will be achieved if salpingectomy or tubal occlusion is performed before IVF. Adhesions 3. Data are insufficient to permit recommendations regarding the effectiveness of alternative treatments such as laparoscopic neosalpingostomy, transvaginal aspiration of hydrosalpingeal fluid, hysteroscopic tubal occlusion, or antibiotic treatment.

SRS and ASRM Practice Committees. Fertil Steril 2008;90:S66–8.

Significance of Peritubal Adhesions Effectiveness of Adhesiolysis • Improved Pregnancy Rates Following Adhesiolysis

• 433 infertile women had laparoscopy 12 months 24 months • Peritubal adhesion effect equal to unilateral tublbal obbistruction Not treated 11% 16% • 25% reduction Treated 32% 45%

Nordenskjold, Acta Obstet Gynecol Scand. 1983;62(6):609‐15. p~0.000 Tulandi. AJOG 1990;162:354‐7.

21 Conclusions • Advantages of Laparoscopy – More than one pregnancy – Fewer multiple pregnancies – Repair pathology THANK – Mitigate problems in addition to infertility • Disadvantages of laparoscopy – Time required to attempt pregnancy YOU! – Risks of surgery – Costs of surgery – Not all conditions are treatable or improved

References (1) References(2)

American Fertility Society. Fertil Steril 1988;49:944–55. Mijatovic. Fertil Steril 2010;93:1338–42. ASRM Practice Committee. Fertil Steril 2006;86:S264–7. Milingos. J Am Assoc Gynecol Laparosc 2000;7:355–61. ASRM Practice Committee. Fertil Steril 2008;90:S66–8. Murray. Fertil Steril 1998;69:41–5. ASRM Practice Committee. Fertil Steril 2012 Mar;97(3):539–45. Nackley. Fertil Steril 1998;69:373–84. Barmat. JARG 1999;16(7):350‐4. Nordenskjold, Acta Obstet Gynecol Scand. 1983;62(6):609‐15. Bontis. Ann NY Acad Sci 2006;1092:199–210. Sagoskin. Hum Rerod 2003 Dec;18(12):2634‐7. Camus. Hum Reprod 1999;14 (5):1243‐9. Shelton. Hum Reprod 1996;11:523–5. Chan. Hum Reprod 2003;18:2175–80. Sowter. Hum Reprod 1997;12:2147–50. Dar. Hum Reprod 2000;15:142–4. SRS and ASRM Practice Committees. Fertil Steril 2008;90:S66–8. Darwish. Acta Obstet Gynecol Scand 2007;86:1484–9. Strandell. Hum Reprod 1999;14:2762–9. de Wit.Hum Reprod 1998;13:1696–701. Strandell. Hum Reprod 2001;16:1135–9. Hammadieh. Hum Reprod 2008;23:1113–17. Tulandi Am J Obstet Gynecol 1990;162:354–7. Johnson. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD002125. Van Voorhis. Hum Reprod 1998;13:736‐9. Kassabji. Eur J Obstet Gynecol Reprod Biol 1994;56:129–32. Zeyneloglu. Fertil Steril 1998;70:492–932. Kerin. J Min Invas Gynecol 2007;14:202–4.

22 When and How to Evaluate the Uterine Disclosures Cavity: HSG vs. Sonohysterography vs  Consultant –Karl– Karl Storz Endoscopy Office Hysteroscopy

Keith Isaacson MD Director MIGS and Infertility, NWH Associate Prof Ob/Gyn Harvard Medical School [email protected]

Indications for Uterine Learning Objectives Cavity Evaluation

--AtAt the conclusion of this presentation,  Evaluation of Abnormal Uterine the participant will be familiar with: Bleeding (AUB) -- The indications to evaluate the uterine  Infertility evaluation cavititity  Location of foreign bodies/lost IUD -- The strengths and limitations of HSG, sonohysterogram and office hysteroscopy  Identification of focal endometrial cancerscancers  Complications of pregnancy  Cervical examination

Indications for Uterine Indications for Cavity Cavity Assessment Assessment

 Evaluation of Abnormal Uterine  Pre and postpost--surgicalsurgical evaluation BleedingBleeding  Evaluation of PostPost--menopausalmenopausal  InfertilityInfertility blee dibldiding  Location of foreign bodies/lost IUD  Identification of focal endometrial cancerscancers  Complications of pregnancy  Cervical examination

23 Normal Menstrual CyclesCycles

 Cycle length - 28 +/-+/-7days7days  Duration of flow -4- 4 +/-+/-2days2days Evaluation of AUB  Blood loss/cycle - 40 +/-+/- 20ml20ml

Excessive Uterine Clinical Indicators BleedingBleeding

 Increase in >2 sanitary pads/day Cycle length < 21days21days  Duration lasting > 3 days more than usualusual Duration offfff flow > 7days7days  Intermenstrual bleeding Blood loss/cycle > 80ml80ml  Cycles > 2 days shorter than usual 11  Blood clots and socially embarrassing ––67%67% develop anemia bleedingbleeding

Hallberg L et al. Acta Obstet Gynaecol Scand, 1966

Causes of abnormal Subjective Assessment uterine bleeding (AUB)

 One third of women with >80 ml/cycle feel their bleeding is  Dysfunctional normalnormal  ItIatrogen iItiic  15% of women with a flow <15  OrganicOrganic ml/cycle feel their flow is heavy

24 Dysfunctional Uterine BleedingBleeding Iatrogenic AUB (anovulatory bleeding)  IUD’sIUD’s  Abnormal uterine bleeding with no  Steroid contraceptives identifiable orggganic disease –– NorplantNorplant  Bleeding due to irregular ovulation – Depot Provera with periods of unopposed estrogen ––OCPOCP – perimenarche  Other medications – perimenopause – Tranquilizers ––PCOPCO

Organic Conditions and Organic lesions and AUB AUBAUB

 Benign pelvic lesions  Complications of pregnancy – submucous myomata – Retained placenta –– intramural myomata (less common)  MalignancyMalignancy – endometrial and endocervical polyps  InfectionInfection ––adenomyosisadenomyosis  Systemic diseases – coagulopathies – hypothryoidism – liver disease

Evaluation of AUB: Step I Evaluation of AUB:Step II

 History  Ovulatory vs Anovulatory – Past medical history (systemic disease) – Regular cycle - 95% ovulatory –– Medications –– BBTBBT ––ContraceptiveContraceptive use ––LHLH kit – Age of AUB onset – Luteal Progesterone ––LMPLMP - r/o pregnancy ––U/SU/S – Cycle regularity – Abnormal bleeding from other sites

25 Anovulatory AUB Ovulatory AUB

 Hormonal evaluation  Coagulopathies (15(15--20%20% of – PCO (FSH, LH, E2) adolescents with excessive regular – Hypothalamic amenorrhea (FSH, E2) uterine bleeding)g)g) ––ProlactinProlactin – primary hemostasis (formation of platelet ––TSHTSH plug)plug)  Hormonal therapy – secondary hemostasis (stabilization of ––ProgestinsProgestins,, E2/P4, OCPsOCPs,, thryoid platelet plug with fibrin deposition) replacement, parlodel – orderly dissolution of clot (fibrinolysis) ––MirenaMirenaIUD - continuous release of local levonorgestrel

Evaluation of Evaluation of the Coagulopathies Reproductive Tract

 CBC and Platelet count  Rule out malignancy  PT - factors II, V, VII, X, fibrinogen – Endometrial biopsy (> 35 y/o)  APTTAPTT-- factors VIII, IX, XII, II, V, X –– Vaginal U/S if post menopausal  Bleeding time - platelet function, platelet number, ––PapPap smear +/+/-- colposcopy and biopsy von Willebrand factor, vascular integrity. ––GuiacGuiac  Platelet function test - replace bleeding time  Rule out infection  vWF screen – vWFAg, vWF:RCo (marker for vWF activity, Factor VIII:C coagulant capacity – cervical cultures – Type O have low nl vWF and high E2 elevates vWF – EB to rule out chronic endometritis  Rule out adenomyosis - MRI, ?hysteroscopy

Indications for Uterine Evaluation of the Uterine Cavity Evaluation CavityCavity

 Premenopausal and ovulatory  D&CD&C  Premenopausal and anovulatory but  Hysterosalpingogram fails hormonal therapy  UltrasoundUltrasound  Postmenopausal bleeding off HRT  Sonohysterography  Unexpected postmenopausal bleeding  Office hysteroscopy on HRTon HRT

26 D&CD&C Vaginal Probe Ultrasound

 Will miss up to 40% of focal lesions  Useful for post menopausal bleeding > 5 such as polyps and fibroids. mm endometrium risk of CA is <3% – Sensitivity and specificityspecificity 56% and 49% (hysteroscopy  Equal to Pipelle office biopsy for 100% and 50%) detecting diffuse endometrial – PPV 83%, NPV -83%-83% carcinoma.carcinoma.  Can evaluate intramural and subserosal fibroids. fibroids.  Only indicated when office biopsy can  Not helpful for focal endometrial lesions not be obtained. such as polyps, myomas or focal cancers.

Loffer FD Obstet Gynecol 73(1): 16-20 1989 Litta P et al. Maturitas 50:117-23, 2005

SIS Vs Hysteroscopy for 33--DD Ultrasound cavity evaluation

 As sensitive and specific for congenital  Similar time requirements uterine anomalies as MRI – 296 sec for SIS –– ArcuateArcuate uteriuteri – 255 sec for flexible OH  Significantly lower pain via VAS with OH ––SeptumSeptum  Patient tolerance – Bicornuate uteri – 78% preferred flexible OH ––DidelphysDidelphys  No significant difference in detecting pathologypathology

Senapita S et al. O-105 Fertil Steril Vol 90 Suppl 1, Sept 2008

Hysteroscopic findings in Indications for Office women with AUB Hysteroscopy

 Menstrual blood loss >60 ml  Evaluation of Abnormal Uterine – 64% with lesion at hysteroscopy (Fraser BleedingBleeding IS Am J Obstet Gyy,necol, 162:1264, 1990  InfertilityInfertility  Post menopausal bleeding  Location of foreign bodies/lost IUD – PPV 78%PPV 78%  Identification of focal endometrial cancerscancers – Negative predictive value 99.4% (Clark T et al. JAMA. 288:1610, Oct 2002  Complications of pregnancy  Cervical examination

27 Uterine Conditions Submucosal Myoma Affecting Fertility

 Uterine fibroids  Submucus fibroids block or decrease – submucoussubmucous the normal vascular supply to the –– intramural?intramural? troppphoblastic tissue.  Endometrial polyps  Present in 8% of infertile women  Intrauterine synechia  Present in >50% of ovulatory women  Congenital defects with menorrhagia  Adenomyosis?

Valle FR. Am J Ob Gyn 1980:37:425-31

Narayan et al. (JAAGL, 1994) Bernard et al. (Eu J Gyn/OB, Jan 2000)2000)

 100 failed IVF cycles with good  Retrospective study of 31 infertile embryosembryos patients with SM myoma undergoing –– 73 normal cavity (control group) myyyomectomy – 27 SM myomata ––FollowedFollowed for 3 years  16/27 had myomectomy, rest shrunk with – 11/31 pregnant (35%) GnRHaGnRHa – Lower pregnancy rate with >1 myoma – Take home baby rate and with concurrent intramural myomata  37% - myomectomy group  19% - controlscontrols

Submucous Myoma TherapyTherapy Endometrial Polyps

 30% - 60% pregnancy rates  Impact on fertility? – Bernard et al, 2000  Present in 24% of infertile women –– Vercillini et al, 1999  Present in >50% of ovulatory women – Giatras et al, 1999 with midcycle spotting

Valle FR. Am J Ob Gyn 1980:37:425-31

28 Intrauterine synechia Intrauterine Adhesions

 Increasing incidence worldwide  Impact on fertility proportional to – D & C after delivery or missed abortion degree of scarring –– Tuberculosis –– density of adhesions – Uterine insult in immunocompromised – degree of cavity occlusion patientspatients – scarring on the uterine wall

Schenker JG,. European J Obstet Gynecol & Repr Endocrinol 1996:65:109-113 Wamsteker K. Endoscopic Surgery for gynecologists. London: Saunders, 1993. 263-76

Congenital Uterine Prevalence of Uterine Abnormalities in Abnormalities Asymptomatic Patients Undergoing IVF

 0.2% - 10% of general population – Shamma et al (1992) - 12/28 (42%) ––SeptumSeptum - decrease vascularity - – Giovanni et al (1998) - 18/100 (18%) all recurrent Ab had a normal HSG and 2 failed cycles – BicornuateBicornuate – Kim et al (1999) - 8/72 (11%) ––DidelphysDidelphys – Ayida et al (1997) - 16/47 (34%) ––TT--shapeshape  37.5% clinical pregnancy rate without intrauterine lesions  8.3% clinical pregnancy rate with

lesionslesions Shamma et al (1992)

Indications for Office Office Based Detection of Hysteroscopy Endometrial CA

 Evaluation of Abnormal Uterine BleedingBleeding  InfertilityInfertility Vaginal probe ultrasound + office hthysteroscopy + PilldPipelle endomet tilrial  Location of foreign bodies/lost IUD biopsy = Hysteroscopy and D&C for  Identification of focal endometrial cancerscancers the detection of endometrial cancer.  Complications of pregnancy  Cervical examination

Tahir M et al. BJOG 107:1058 Aug 2000

29 Does hysteroscopy influence Indications for Office the prognosis of early stage Hysteroscopy Endometrial Cancer?  Means of diagnosis compared  Evaluation of Abnormal Uterine – Endometrial biopsy BleedingBleeding –– Hysteroscopy  InfertilityInfertility  Location of foreign bodies/lost IUD  ResultsResults  Identification of focal endometrial – Higher recurrence with endometrial cancerscancers biopsybiopsy  Complications of pregnancy – No difference in peritoneal cytology or 5 yr. survival rates.  Cervical examination

Ben-Arie et al. Int J Gynecol CA July 2008

Indications for Office Information Changes Hysteroscopy Management

 Submucous  Pre and postpost--surgicalsurgical evaluation myomatamyomata  Evaluation of PostPost--menopausalmenopausal –– Type 0 - 100% blee dibldiding w/in cavity  Minor surgical procedures –– Type I ->- > –– Visual biopsy 50% w/in –– Insertion of tubal occlusion device cavitycavity –– Adhesiolysis –– Type II --<< –– Polypectomy 50% w/in cavitycavity deBlok S, et al: Gynaecol Enosc 4:243-246, 1995

Office hysteroscopy nonnon-- disposable equipment

 Hysteroscope ––FlexibleFlexible – Rigid  12, 25, 30 degree angled lenses  Operative instruments  CartCart – Light source, light cacable,ble, monitor, camera (on cart or built into scope, image capture)capture)

30 Costs and Reimbursements

 Capital equipment - $12,000$12,000--$15,000$15,000 ––FlexibleFlexible scope –– MonitorMonitor – Light source ––CameraCamera ––CartCart

Questions Questions

 Appropriate modalities to evaluate the  Indications for evaluation of the uterine cavity include all of the uterine cavity include which of the followinggp except followinggg a) Vaginal probe ultrasound a) Pelvic pain b)b)33--DD ultrasound b) Recurrent yeast infection c) HSG c) Dyspareunia d) Office hysteroscopy d) Recurrent miscarriage e) Saline sonography

Questions Questions

 Sonohysterography has a better  Office hysteroscopy is a procedure sensitivity and specificity than HSG for that most often requires local detectingpg endometrial polypyps anesthesia for ppgain management ––TrueTrue  TrueTrue ––FalseFalse  FalseFalse

31 Disclosures When and How to Remove Intramural Fibroids to I have no financial relationships to disclose. Improve Fertility William W. Hurd, MD Professor of Gynecology and Obstetrics

University Hospitals Case Medical Center Case Western Reserve University School of Medicine

Learning Objectives Incidence of Fibroids

At the conclusion of this presentation, Hysterectomy specimens 70% the participant should be able to: Reproductive-age women 40% 1. Discuss what is known about the relationship Infertility women 10% between fibro ids an d in fert ility Unexpl a ine d in fert ility ? 2. List guidelines for when to perform myomectomies in patients with infertility 3. Distinguish the relative advantages of the various surgical approaches for myomectomy

Fibroids and Infertility Types of Fibroids

Some fibroids: • Intracavitary • Decrease fertility • Submucosal (Distorts cavity) • Increase spontaneous abortions • Increase pregnancy complications • Intramural Questions 1. When should we remove fibroids • Subserosal in infertile women? • Pedunculated 2. How?

32 Fibroids and Infertility: Do Submucosal and Intracavitary Possible Mechanisms Fibroids Decrease Fertility? 1. Interference with sperm/embryo transport Compared with infertile women without fibroids: – Occlusion of the tubal ostea ↓ Implantation rate – Changes in uterine contractility ↓ Clinical pregnancy rate – Elongation of the uterine cavity ↓ Ongoing ↓ Pregnancy/live birth rate 2. Impair implantation ↑ Spontaneous abortion rate – Intracavitary/Submucosal – Intramural?

(Pritts 2009)

Do Intramural Fibroids Do Intramural Fibroids Decrease Fertility? Decrease Fertility?

Intramural Fibroids <7 cm (Not Compressing Uterine Cavity)

Effects of intramural fibroids 60% IVF-ICSI Results (n=245) on IVF: 40% Fibroids Control OR Control Fibroid Implantation rate 16% 28% .62 (.48-.80) 20% 0% Delivery rate 31% 41% .69 (.50-.95) Pregnancy Miscarriage

(Benecke 2005) (Oliveira 2004)

Effects of Size and Position Do Fibroids Increase on IVF-ICSI Pregnancy Complications?

Pregnancy Obstetric and delivery outcomes for women 60% 50% with and without leiomyomas 40% 30% 20% 10% 0% Control Subserosal 0.2 - 2.0 cm 2.0 - 4.0 cm 4.0 - 6.9 cm Intramural

Miscarriage 60% 50% 40% 30% 20% 10% 0% Control Subserosal 0.2 - 2.0 cm 2.0 - 4.0 cm 4.0 - 6.9 cm Intramural (Stout 2010) (Oliveira 2004)

33 Fibroids >5 cm and Does Myomectomy Pregnancy Complications Improve Fertility or Miscarriage Rates? Hysteroscopic Myomectomy: Obstetric outcomes comparing women with leiomyomas – Retrospective (n= 29): <5 cm to those with leiomyomas >5 cm – 25 with intracavitary fibroids – 4 with submucosal fibroids <5

80% mm 70% 60% 50% Before 40% After 30% – No Pregnancy 20% 10% 0% complications Clinical Spont Abortion Term Pregnancy Pregnancy

(Stout 2010) (Shokeir 2005)

Myomectomy and Pregnancy Myomectomy and Rate Spontaneous Abortion Rates The only RCT • Intramural or Subserosal Fibroids >5 cm 60% • Retrospective, n = 51 50% n=181 40% Spontaneous Abortion Rates Control 30% 20% Myomectomy 60% 10% 40%

0% 20%

Intramural- Subserosal- 0% Submucosal Intramural submucosal intramural Before After

(Casini 2006) (Li TC 1999)

Uterine Evaluation for Infertility Ultrasonography

• Transvaginal Ultrasound Measure: • Hysterosalpingogram • Location • Sonohysterogram • Number •Size • 3-D ultrasound? •MRI?

34 Hysterosalpingogram Sonohysterogram

Determines • Tubal patency Determines • Distortion of the • Size uterine cavity • Location relative to the uterine cavity

3-D Ultrasonography MRI

• Most accurate Uncertain role • Most expensive • Offers little more Future: information 3-D sonohysterogram

Surgical Approaches to Fibroids When to Remove Fibroids in the Infertile Patient 1. Hysteroscopic 3. Robotic 1. Symptomatic fibroids • Intracavitary • Single Intramural – Menorrhagia • Some – Pressure symptoms related to size Submucosal 4. Open 2. LiLaparoscopic 3. Infertile patients • Large – All Intracavitary or Submucosal fibroids • Pedunculated Submucosal – Intramural Fibroids >5 cm • Subserosal • Intramural – Infertility unresponsive to therapy? • Intramural • Submucosal?

35 Hysteroscopic Approach Brazil Classification Point Penetration Size Base Location Lateral • Intracavitary 0 0 <2 cm <1/3 lower No 1 <50% 2-5 cm 1/3-2/3 middle Yes • Submucosal 3 >50% >5 cm >2/3 upper IdikfIncreased risk of – Uterine perforation Suggested Approach – Infertility related to 0-4 Hysteroscopic: Low complexity Asherman’s adhesions 5-6 Hysteroscopic: High complexity – Placenta accrete 7-9 Non-hysteroscopic

(Lasmar 2005)

Hysteroscopic Myomectomy Hysteroscopic Approaches Pearls 1. Resectoscope Advantage • Preoperative GnRH agonist if >2 cm – Deeper resection • Vasopressin injection into cervix – Reaches corners (10 u/50 cc NS) – Less Expensive • Careful Is & Os 2. Intra-uterine morcellator (Myosure®) (TrueClear®) – Good adhesion of bag to perineum Advantages – Weighing device – No electrosurgery – Know when to quit – Normal saline –Easier

Robotically Assisted Laparoscopic Approach Laparoscopic Approach

• Single submucosal/intramural fibroids Fibroids involving myometrium • Submucosal • Intramural • Submucosal

Indman

36 Risk of Laparoscopic Approach Laparoscopic Myomectomy for the Infertility Patient Pearls

•Uterine rupture during pregnancy • Vasopressin injection (10 u/50 cc NS)

ASRM Guideline: “the inability to effectively • V-lock® suture close the myometrium Cover with adhesion barrier laparoscopically could contribute to a higher • Adhesions Barrier incidence of this complication”

(ASRM 2004)

Laparotomy Myomectomy Laparotomy Myomectomy Pearls

Decreased • Preoperative GnRH agonist • Blood Loss? • Vasopressin • Subsequent uterine rupture? • Tourniquets • Recurrence? • Adhesion barrier Increased • Discomfort • Wound infection • Adhesions

Adhesion Prevention Summary after Myomectomy Fibroids in Infertile Women • Proven to decrease adhesions: 1. All infertility patients are evaluated for fibroids – Oxidized regenerated cellulose Interceed® 2. Fibroids should be removed in infertile patients – Hyaluronatecarboxymethycellulose when they are film Seprafilm® (laparotomy only) • Intracavitary • No data on subsequent fertility or • Submucosal other long-term outcomes • Intramural fibroids >5 cm

• No benefit: 3. Surgical approach depends on location, size, – 4% icodextrin solution: Adept® equipment, and training

(Robertson 2010) (Trew 2011)

37 References

Benecke C, Kruger TF, Siebert TI, Van der Merwe JP, Steyn DW. Effect of fibroids on fertility in patients undergoing assisted reproduction. A structured literature review. Gynecol Obstet Invest. 2005;59(4):225-30. Casini ML, Rossi F, Agostini R, Unfer V. Effects of the position of fibroids on fertility. Gynecol Endocrinol. 2006 Feb;22(2):106-9. Lasmar RB, Barrozo PR, Dias R, Oliveira MA. Submucous myomas: a new presurgical classification to evaluate the viability of hysteroscopic surgical treatment--preliminary report. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):308-11. Li TC, Mortimer R, Cooke ID. Myomectomy: a retrospective study to examine reproductive performance before and after surgery. Hum Reprod. 1999 Jul;14(7):1735-40. Oliveira FG, Abdelmassih VG, Diamond MP, Dozortsev D, Melo NR, Abdelmassih R. Impact of subserosal and intramural uterine fibroids that do not distort the endometrial cavity on the outcome of in vitro fertilization-intracytoplasmic sperm injection. Fertil Steril. 2004 Mar;81(3):582-7. Parker WH, Olive DL, Pritts EA. Fibroids and pregnancy outcomes. Fertil Steril. 2012 Jul;98(1):e13. Practice Committee of the American Society for Reproductive Medicine. Myomas and reproductive function. Fertil Steril. 2004 Sep;82 Suppl 1:S111-6: Pritts EA, Parker WH, Olive DL. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril. 2009 Apr;91(4):1215-23. Qti?Questions? Robertson D, Lefebvre G, Leyland N, Wolfman W, Allaire C, Awadalla A, Best C, Contestabile E, Dunn S, Heywood M, Leroux N, Potestio F, Rittenberg D, Senikas V, Soucy R, Singh S; Society of Obstetricians and Gynaecologists of Canada. Adhesion prevention in gynaecological surgery. J Obstet Gynaecol Can. 2010 Jun;32(6):598-608. Shokeir TA. Hysteroscopic management in submucous fibroids to improve fertility. Arch Gynecol Obstet. 2005 Nov;273(1):50-4. Stout MJ, Odibo AO, Graseck AS, Macones GA, Crane JP, Cahill AG. Leiomyomas at routine second-trimester ultrasound examination and adverse obstetric outcomes. Obstet Gynecol 2010;116:1056–63. Trew G, Pistofidis G, Pados G, Lower A, Mettler L, Wallwiener D, Korell M, Pouly JL, Coccia ME, Audebert A, Nappi C, Schmidt E, McVeigh E, Landi S, Degueldre M, Konincxk P, Rimbach S, Chapron C, Dallay D, Röemer T, McConnachie A, Ford I, Crowe A, Knight A, Dizerega G, Dewilde R. Gynaecological endoscopic evaluation of 4% icodextrin solution: a European, multicentre, double-blind, randomized study of the efficacy and safety in the reduction of de novo adhesions after laparoscopic gynaecological surgery. Hum Reprod. 2011 Aug;26(8):2015-27.

38 DISCLOSURE TUBAL LIGATION REVERSAL I have no financial relationships to disclose. VERSUS IVF

Professor Victor Gomel

Victor Gomel

• The advantages and drawbacks of IVF have been discussed in my earlier • The first option (reversal) is designed presentation and will not be repeated to restore tubal function. here.

• Whereas, the second (IVF),replaces • However, we will review the ittimportant it. factors that must be taken into account in recommending the proper treatment modality..

Victor Gomel Victor Gomel

Although performed less frequently than The precision afforded by the before, reversal procedures have as yet microsurgical technique and use of not suffered the abandonment other magnification allow precise dissection of anastomotic tubal procedures have the occluded ends, ppproper alignment of experienced. the proximal and distal segments of tube, Yet, microsurgery finds its ultimate and excellent apposition of each layer application in tubo-tubal anastomosis. with very fine non-reactive sutures.

Victor Gomel Victor Gomel

39 INFERTILITY- INVESTIGATION

• Clinical assessment** Furthermore since in the vast majority of reversal cases the available tubal • Semen analysis segments are normal, the outcome is an • Assessment of ovulation anatomically and physiologically normal, • Assess tubal factors- HSG albeit shortened fallopian tube. * Sonography is part of clinical assessment * Obtain the operative report of the Gomel V. McComb PF. J Reprod Med. RBM Online. 2006; 51: 177‐ 184 prior tubal sterilization. Le Toucher, in Maygrier JP. Paris,1822 Victor Gomel Victor Gomel

IVF AS PRIMARY TREATMENT FURTHER CONSIDERATIONS

• Male factor infertility • Report of the prior tubal sterilization

• Age of female partner • Size of remaining tubal segments?

• Tubal disease + Male factor • Need for HSG and/or laparoscopy?

• Inoperable tubal disease • Health insurance coverage, costs, etc.

• Others: ie. need for PGD • Wishes of the patient/ couple…

Gomel V. Reproductive Surgery in Reconstructive & Reproductive Surgery, Informa, London 2010 Gomel V. RBM Online. 2007; 15: 403‐ 407

Victor Gomel Victor Gomel

ISTHMIC-ISTHMIC ISTHMIC-ISTHMIC ANASTOMOSIS ANASTOMOSIS

Victor Gomel Victor Gomel

40 ISTHMIC-ISTHMIC ANASTOMOSIS ISTHMIC-ISTHMIC ANASTOMOSIS

Victor Gomel Victor Gomel

ISTHMIC- AMPULLARY ISTHMIC-ISTHMIC ANASTOMOSIS ANASTOMOSIS

Gomel V. RBMOnline. 2007; 15: 403-7 Gomel V. RBMOnline. 2007; 15: 403-7 Victor Gomel Victor Gomel

PREPARATION OF PREPARATION OF AMPULLAY STUMP AMPULLAY STUMP

Gomel V. RBMOnline. 2007; 15: 403-7 Victor Gomel Victor Gomel

41 ISTHMIC- ISTHMIC- AMPULLARY AMPULLARY ANASTOMOSIS ANASTOMOSIS

Victor Gomel Victor Gomel

CALCIFIED TUBAL PREGNANCY

Victor Gomel Victor Gomel

IFFS 1974: 8TH WORLD CONGRESS

BUENOS AIRES ARGENTINA

Victor Gomel Victor Gomel

42 STERILIZATION REVERSAL- LAPAROSCOPY STERILIZATION REVERSAL- MICROSURGERY

Patients*(n=118) No. % Authors Kim SY* Kim JD° Not pregnant 20 16.9% Total followed 922/ 1118 35/ 387 Total I.U. pregn. 463 (50%) 329 (90%) Ectopppgic pregnancy 2 1.7% Viable births 366 (40%) 295 (82%) Intrauterine pregn. 96 81.4% Ongoing pregn. 31 ( 3%) 8 ( 2%) Spontaneous abort 90 (10%) 14 ( 4%) Viable birth 93 78.8% Ectopic pregn. 42 ( 5%) 6 ( 2%) ** Long term follow up. *Followed more than 5 years. °Followed more than 2 years. Gomel V. Fertil Steril. 1980; 33: 587-97 Kim SY et al Fertil Steril 1997;68:865‐70 Victor Gomel Kim JD et al Fertil Steril 1997;68:875‐80

✪ STERILIZATION REVERSAL- MICROSURGERY STERILIZATION REVERSAL- LAPAROSCOPY

(n=164/261*) Patients % Patients*(n=32) No. %

Viable births 60.0% Total IU. Pregnancy 17/32 53% Spontaneous abortion 18.0% IU> pregn <38 years 10/17 59% Ectopic pregnancy 7.7% Viable births 13 41% ✪ Procedures performed between Jan 1985- Dec 2005. Post-op hospital stay 2-3 days *89 (34%) patients lost to follow–up, 8 did not try to conceive. ** Single suture tubal anastomosis.

Dubuisson JB, Chapron C. Curr Opin Obstet Gynecol 1998;10: 307-13 Gordts Sylvie. Fertil Steril.2009;92: 1198-202 Victor Gomel Victor Gomel

STERILIZATION REVERSAL- LAPAROSCOPY STERILIZATION REVERSAL- LAPAROSCOPY

Outcome No. Patients % Patients*(n=202) No. % Total followed † 186 93% Total patients∞ 102 I.U. pregnancy 154 83% I.U. ppgregnancy 64 62.7% Viable births 98 53% Viable births 49 50.5% Ongoing pregn. 31 17% Spontan abort. 25 13% Ectopic pregnancy 5 4.9% Ectopic pregn. 5 3% **Single suture tubal anastomosis. ∞Pre-selected by laparoscopy for length of tube: proximal > 3 cm, distal > 4cm. **Lost to follow up (n=15), not attempting pregn.(n=1). †Follow up >12 m Bissonette F et al.Fertil Steril 1999;72: 549 Victor Gomel Yoon TK et al. Fertil Steril 1999; 72:1121‐26

43 STERILIZATION REVERSAL- LAPAROSCOPY ROBOTIC TUBAL ANASTOMOSIS

Patients*(n=51) No. % 10 mm Spontaneous abortion 3 8 mm X 2 12 mm Viable birth 12 23.5%

Ectopic pregnancy 12 23.5%

• Retrospective study. • Single 5-0 Vicryl suture to mesosalpinx and single 7-0 Vicryl suture to approximate the two segments of tube at 12 o’clock position. 15

Ayoubi JM. In print. 2012 Dharia Patel SP et al. Fertil Steril. 2008; 90: 1175‐ 79

Victor Gomel Victor Gomel

ROBOTIC TUBAL ANASTOMOSIS ROBOTIC TUBAL ANASTOMOSIS

OUTCOME ROBOT (n=18) OPEN (n=10)

IU pregnancy 5 3

Spont. abortion 2

Tubal pregnancy 4 1

Dharia Patel SP et al. Fertil Steril. 2008; 90: 1175‐ 79

Dharia Patel SP et al. Fertil Steril. 2008; 90: 1175‐ 79

Victor Gomel Victor Gomel

ROBOTIC TUBAL ANASTOMOSIS FACTORS AFFECTING OUTCOME • “Robotic-assisted surgery appears to • AGE OF FEMALE PARTNER provide the same surgical outcomes and cost effectiveness when compared with traditional open tubal anastomoses.

• The high patency rates provide optimism for the role of robotics in trining programs.”

Dharia Patel SP et al. Fertil Steril. 2008; 90: 1175‐ 79 Gomel V. Reproductive Surgery in Reconstructive & Reproductive Surgery, Informa, London 2010

Victor Gomel Victor Gomel

44 PREGNANCY OUTCAME AFTER FACTORS AFFECTING OUTCOME MICROSURGICAL STERILIZATION REVERSAL

90 • AGE OF FEMALE PARTNER 80 70 • 60 SURGICAL TECHNIQUE 50 <36 years 40 36‐39 years • LENGTH OF RECONSTRUCTED TUBE 30 40‐43 years 20 10 • OTHERS 0 0 mo612182436 months

Gordts Sylvie et al. Fertil Steril.2009;92: 1198-202 Gomel V. Reproductive Surgery in Reconstructive & Reproductive Surgery, Informa, London 2010

Victor Gomel Victor Gomel

The real dilemma lies with the Microsurgical tubal anastomosis yields a ‘commercialization’ of IVF, and its birth rate that exceeds 60%, without frequent use as primary treatment for increased risk of multiple pregnancy. infertility.

It offers the couple multiple cycles in The dilemma is heightened by the fact which to achieve conception naturally, and that reconsttitructive tbltubal microsurgery is the opportunity to have more than one being taught and practiced less and less, pregnancy from a single intervention. thereby eliminating this credible surgical option in most centers.

Gomel V. RBM Online. 2007; 15: 403‐ 407 Gomel V. RBM Online. 2007; 15: 403‐ 407

Victor Gomel Victor Gomel

“There is good evidence to support the recommendation for microsurgical anastomosis for tu ba l liga tion reversa l. ” “…it can be accomplished by mini-laparotomy as an outpatient procedure.”

Fertil Steril. 2012; 97: 539‐ 459

Victor Gomel Victor Gomel

45 THANK YOU MERCI GRACIAS Comparable results may be obtained by ありがとう laparoscopy if the procedure is performed “in an OBRIGADO identical fashion to open microsurgical tubal anastomosis.” Operating times are prolonged. TEŞEKÜRLER GRAZZIE “Only surgeons who are very facile with laparoscopic suturing and who have extensive EYXAPIΣТΩ ٙشكرا training in conventional tubal microsurgery should attempt this procedure.”

Fertil Steril. 2012; 97: 539‐ 459 Victor Gomel Victor Gomel

46 DISCLOSURES Ovarian Surgery to Improve Fertility: Endometriomas and Ovarian Drilling I have no financial relationships to disclose.

William W. Hurd, MD Professor of Obstetrics and Gynecology

University Hospitals Case Medical Center Case Western Reserve University School of Medicine

LEARNING OBJECTIVES ENDOMETRIOMA

At the conclusion of this presentation, the participant • A “chocolate cyst” arising from growth of should be able to: ectopic endometrial tissue within the ovary 1. Discuss what is known about the relationship between endometriomas and infertility • Often adherent to surrounding structures, 2. Distinguish the relative advantages of the (peritoneum, fallopian tubes, bowel) various surgical approaches to endometriomas 3. List guidelines for when to treat polycystic • Chocolate fluid: menstrual debris from the ovaries with ovarian drilling shedding and bleeding from implants

How Does Endometrial Tissue INCIDENCE Get into the Ovary?

Endometriosis Hypothetical possibilities: • 10% of all women 1. Retrograde menstruation • 30% of women with chronic pelvic pain • Progressive invagination of ovarian cortex • 20-40% of infertile women • Invades ovary • Enters ovarian cysts at the time of ovulation Endometriomas 2. Embryonic Rests • 10% of all women with endometriosis 3. Metaplasia of epithelial inclusions in the ovary • 60% of women with moderate/severe (“coelomic metaplasia”) endometriosis

(Stepniewska 2009)

47 Ultrasound Appearance of Endometriomas Differential Diagnosis

• Ground glass appearance: 1. Hemorrhagic functional cyst (resolves over time) homogeneous low to medium level echoes 2. Ovarian malignancies • Thick walled, cystic mass – Develop in <1% of women with endometriosis • Uni- or multi-locular – Cell types: clear cell and endometrioid Ca • Can have a solid, – CA-125 is of little help (usually elevated) nodular component – Always send tissue for histopathology diagnosis

(Kobayashi 2007)

Endometrioma SYMPTOMS Treatment Options

• Symptoms of endometriosis • Often asymptomatic • Observation • Ruptured endometrioma • Medical Therapy = PID or appendicitis: • Surgery Peritonitis ↑WBC Fever • What should we do when we puncture a cyst and find chocolate fluid?

Observation Observation Management Plan

Candidates: • Ultrasound every 6 months x 1 year, • Previous histological diagnosis of endometriosis then annually • Recurrent asymptomatic adnexal mass consistent with an endometrioma • Repeat surgery for changes in: •Size <4 cm – Symptoms – Cyst size or complexity

(Hurd 2012)

48 Surgical Management of Medical therapy Endometriomas

Medical options: Indications: – GnRH Agonists •Pain – Progestins • Exclusion of malignancy – OCPs • Infertility – Prior to IVF? • Treatment for endometriosis symptoms

• Will not resolve endometrioma

Endometriomas and Infertility Risk of Endometrioma Resection

Endometrioma removal is controversial! • Decreased “ovarian reserve”

• Advantage: • Mechanism: Follicles adjacent to the cyst destroyed Treatment of pelvic endometriosis (outside the ovary) improves fertility • Measurable changes after resection: – Increased ovarian resistance to ovulation induction • Disadvantage: – Decreased oocyte number and quality for IVF Endometrioma resection damages the ovary – Premature ovarian failure (2% if bilateral)

(Tsoumpou 2009) (Busacca 2006)

Should Endometriomas be Resected Prior to IVF? Recommendation Prior to IVF

Endometrioma resection results in : Remove endometriomas >4 cm prior to IVF • Slower follicle growth (longer stimulation) Rationale: • ↑FSH requirements • Confirm the diagnosis histologically • Improve access to follicles • ↓ Mature oocytes • No change in rates of – Fertilization – Pregnancy

(Tsoumpou 2009) (Kennedy 2005)

49 Surgical Approaches Oophorectomy

• Oophorectomy • Best Approach After childbearing completed • Aspiration • Recurrence uncommon • Cyst wall resection • Most likely to relieve pain (stripping technique) • Removing attached peritoneum with ovary • Fenestration and ablation might minimize the risk of ovarian remnant syndrome

Aspiration Cyst wall resection

• Puncture without aspiration can result in peritonitis • Remove entire cyst wall using a stripping technique • Cyst should be completely drained and rinsed • Recurrence rate: 6% • Recurrence rate: 88%

Fenestration and ablation Why are Recurrence Rates so High?

• Technique: Cyst wall resection: 6% – Remove section of the cyst wall Fenestration/ablation: 30% – Irrigate cyst Aspiration: 88% – Coagulate (or laser vaporization) inside of cyst • Less symptom relief Reason: endometrial glands and stroma • Lower pregnancy rate involves 60% (10-90%) of cyst wall • Recurrence rate: 30% for a depth of <2 mm

(Hart 2005) (Muzii 2007)

50 How to Decrease Recurrence Bottom Line: Endometriomas

• Pregnancy • Most endometriomas should be removed • Breast Feeding • Estrogen-progestin OCPs • Cyst wall resection is the goal

(Protective effect disappears after • Recurrence is always a risk OCP cessation)

• OCPs after surgery for those not attempting pregnancy

(Muzii 2000) (Seracchioli 2010)

Ovarian Drilling for PCOS: Ovarian Diathermy Indications

• Laparoscopic “wedge resection” equivalent for • Women with PCOS who do not ovulate with PCOS fertility medicines: Metformin • Electrocautery or a laser is used to destroy parts Clomiphene citrate of the ovaries FSH

• Ovulation temporarily resumes in most women • Women with PCOS who do not respond to clomiphene citrate and cannot afford FSH or IVF

Ovarian Drilling Technique Results

(No standard technique) • Androgens decrease within days • Laparoscopy • Puncture ovary 4-10 times using • Spontaneous ovulation occurs in most women electrosurgical needle (or laser fiber) • Probe: 8 mm distal stainless steel needle with insulated shaft • Electrosurgical setting: 30 watts for 5 seconds • Stay on side away from tube and peritoneum

(Amer 2002)

51 How Well doe it Work? Risks of Ovarian Drilling No randomized controlled trials 1. Risks of related to laparoscopy (< 1/1,000) Based on several series totaling >1,000 women: • 80% ovulate 2. Risk specific to ovarian drilling • 50% become pregnant – Peri-ovarian adhesions (usually mild) (in women with no other fertility problems) – Premature ovarian failure? Best Prognosis: • Younger women • BMI < 25 Kg/M2

(Stegmann 2003)

Bottom Line: Ovarian Drilling

• Relatively safe surgical treatment for women with PCOS resistant to fertility drugs Questions? • Spontaneous pregnancy rates within 6 months of surgery are remarkable

• Ovarian adhesions are the primary concern

REFERENCES

Amer SAK, Li TC, Cooke ID. Laparoscopic ovarian diathermy in women with polycystic ovarian syndrome: a retrospective study on the influence of the amount of energy used on the outcome. Hum Reprod 2002; 17 (4): 1046-51. Busacca M, Chiaffarino F, Candiani M, et al. Determinants of long-term clinically detected recurrence rates of deep, ovarian, and pelvic endometriosis. Am J Obstet Gynecol 2006; 195:426. Hart RJ, Hickey M, Maouris P, et al. Excisional surgery versus ablative surgery for ovarian endometriomata. Cochrane Database Syst Rev 2005; :CD004992. Hurd WW, Redwine DB. Chapter 13. Endometriosis. In: Bieber E, Sanfilippo J, Horowitz I, Shafi F, Eds. Clinical Gynecology, 2nd Ed, Philadelphia: Elsevier Publishing, 2012. Kennedy S, Bergqvist A, Chapron C, et al. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod 2005; 20:2698. Kobayashi H, Sumimoto K, Moniwa N, Imai M, Takakura K, Kuromaki T, Morioka E, Arisawa K, Terao T. Risk of developing ovarian cancer among women with ovarian endometrioma: a cohort study in Shizuoka, Japan. Int J Gynecol Cancer. 2007 Jan-Feb;17(1):37-43. Muzii L, Bellati F, Palaia I, et al. Laparoscopic stripping of endometriomas: a randomized trial on different surgical techniques. Part I: clinical results. Hum Reprod 2005; 20:1981. Seracchioli R, Mabrouk M, Frascà C, et al. Long-term cyclic and continuous oral contraceptive therapy and endometrioma recurrence: a randomized controlled trial. Fertil Steril 2010; 93:52. Stegmann BJ, Craig HR, Bay RC, Coonrod DV, Brady MJ, Garbaciak JA Jr. Characteristics predictive of response to ovarian diathermy in women with polycystic ovarian syndrome. Am J Obstet Gynecol. 2003 May;188(5):1171-3. Stepniewska A, Pomini P, Bruni F, Mereu L, Ruffo G, Ceccaroni M, Scioscia M, Guerriero M, Minelli L. Laparoscopic treatment of bowel endometriosis in infertile women. Hum Reprod. 2009 Jul;24(7):1619-25. Tsoumpou I, Kyrgiou M, Gelbaya TA, Nardo LG. The effect of surgical treatment for endometrioma on in vitro fertilization outcomes: a systematic review and meta-analysis. Fertil Steril 2009; 92:75.

52 Surgical Treatment of Disclosures Uterine Anomalies: Indications and  Consultant –Karl– Karl Storz Endoscopy Techniques

Keith Isaacson, MD Associate Professor of Obstetrics and Gynecology Harvard Medical School Boston, MA USAUSA

Objectives Infertility Evaluation

 Identify uterine pathology that impacts  Semen Analysis fertilityfertility  Ovarian Reserve Assessment  DefineDefineDefine the uterine surgical techniques  Tubal patency that will enhance fertility  Uterine assessment  Review the complications and the – Vaginal probe ultrasound success rates of uterine surgery that ––HSGHSG enhances fertility – Saline sonography – Office hysteroscopy

Should OH be a routine part Intrauterine pathology of the infertility evaluation? impacting fertility

 Lorusso, F et al 2008 (866 cycles)  Uterine fibroids – 555 pts before first IVF – 311 after 2 or more failed IVF  Intrauterine Adhesions –– 40% with intrauterine pathology  Intrauterine polyps  Hinkley MD JSLS 2004 (Stanford Med)  – 1000 patients prior to IVF Proximal Tubal occlusion 32% with polyps  Uterine septum 3% submucous myomas 3% adhesions  Adenomyosis 0.5% septum 0.3% retained POCs 0.3% bicornuate

53 Information Changes Myomas and reproductive Management functionfunction

1. Cervical displacement can reduce exposure to sperm  Submucous 2. Enlargement or deformity of the uterine cavity that may myomatamyomata interfere with sperm migration and transport 3. Obstruction of the proximal fallopian tubes –– Type 0 - 100% 4. Altered tubo-ovarian anatomy, interfering with ovum w/in cavity capture 5. Increased or disordered uterine contractility that may –– Type I ->- > hinder sperm or embryo transport or nidation 50% w/in 6. Distortion or disruption of the endometrium and implantation due to atrophy or venous ectasia over or opposite cavitycavity a submucous myoma –– Type II --<< 7. Impaired endometrial blood flow 8. Endometrial inflammation or secretion of vasoactive 50% w/in substances cavitycavity deBlok S, et al: Gynaecol Enosc 4:243-246, 1995 Ed Bulliten, Fertil Steril 2008;90:S125–30

Fertility after Hysteroscopic SM myomata and Resection of infertilityinfertility Submucous Myomas

 Pritts reported significantly lower pregnancy  No prospective randomized trials rates (risk ratio, 0.32), implantation rates  Giatras et al. 1999 JMIG (risk ratio, 0.28), and delivery rates (risk – 41 infertile patients ratio, 0.75) in patients with submucosal –– 61% pregnancy rate  56% delivery rate myomas and abnormal uterine cavities, in  Betocchi et al F&S 2008 comparison with infertile control women – Beneficial treatment of SM myomata <1.5 cm in IVF without myomas. patients.  Shokeir TA (Arch of Gynecol Obstet 2005)  Donnez and Jadoul also confirmed that only – 3% to 63% after resection del rate submucous myomas have a negative impact – Ab rate reduced from 61% to 26% after resection on embryo implantation.

Intrauterine adhesions Therapy for Asherman’s and fertility

 6%6%--20%20% of women with primary infertility  Recurrence of adhesions  25% of women with recurrent Ab – 20%20%--60%60% depending on severity  25%25%--40%40% after pppppost partum D&C  Methods to prevent recurrence ––OCPsOCPs  6% of women with 2 or more failed IVF with good embryo quality ––IUDIUD – Foley balloon  Found after myomectomy, UAE, Infection ––HAHA  43% of women with Asherman’s present ––EstrogenEstrogen with infertiltiy – Second look hysteroscopy

Yu et al. Fertil Steril 2008;89:759–79

54 Success of Asherman’s Recurrent IVF failure therapytherapy

 Pace et al, pregnancy rate improved from 28.7% before surgery to 53.6% after hysteroscopic treatment.  421 pts --randomizedrandomized  Women with two or more previous unsuccessful pregnancies, the live birth rate improved from 18.3% preoperatively to – 211 with no OH – 21% PR21% PR 68.6% postoperatively.  The pregnancy rate after hysteroscopic lysis of intrauterine –– 210 with OH adhesions in women who wanted to have a child has been about 74% (468 out of 632), which is much higher than found  154 normal cavities – 32% PRPR32% in untreated women (46%).  56 abnormal cavities (26%) repaired at  The pregnancy rate after treatment in women with infertility is about 45.6% (104 out of 228); the successful pregnancy rate diagnosisdiagnosis–– 30% PR P=0.044 after treatment in severe cases is reported to be consistently lower (18 out of 55 or 33%). For women with previous pregnancy wastage, both the pregnancy rate and the live birth rate after treatment are reasonably high (121 out of 135 or 89.6% and 104 out of 135 or 77.0%, respectively). Dimirol A, Gurgan T Reproductive Med Online 8:590 2004

Clin Exp Obstet Gynecol 2003;30:26–8.

Pregnancy rates after Hysteroscopic tubal Polypectomy occlusion for hydrosalpinx

Stametellos L et al. Arch Gynecol Obstet  Rosenfield R et al F&S 2005 277:395-9 2008 – One obese patient, one pregnancy – 83 patients with primary infertility and  Hitkari et al F&S 2007 endometrial polyps by hysteroscopy –– 5titithhdli5 patients with hydrosalpinx and di prior surg. – 61% pregnancy rate, 52% delivery rate post  Successful placement in 2/5 polypectomy in 33--1818 mos post procedure  0 pregnancies  Lass A et al J Assist Repro and Genet 1999  Kerin J et al F&S 2007 (Bourne Hall) – 2 patients, 2 pregnancies – 24 cases – reduction in miscarriage rate with – Tissue encapsulation of proximal insert between 4-4- polypectomy 43 mos in 545 women

VERSAPOINT System for Uterine septum repair Bipolar Hysteroscopic Surgery

 119 patients (32%, 14% IVF failure,  1.6 mm (5 F) in diameter SAB) with septum age matched to 116  Two poles separated 2 mm at distal shaft controls ((, 20%, 6% IVF fail, ,) SAB) byyy ceramic insulator  After repair - Both groups equal  Electrodes designed for variable tissue effects  Miscarriage rate drops from 91% to – Ball tip –precise vaporization 17% (Sanders J Repro Med 51 2006) and desiccation  Spring tip –rapid tissue vaporization and desiccation – Twizzle tip – vaporization and needle-needle-like cuttingcuttinglike  Given small size and focused tissue effects, best for Ozgur, k et al Reproductive Biomedicine Online 14:335 2007 – polypectomy, adhesiolysis, vaporization of smaller submucous myomata

55 Compostion11 of Gases Found by Uterine Vascularity Hysteroscopic Electrosurgical Vaporization* Bipolar Unipolar AirAir (normal saline) (glycine)

Hydrogen 51.051.0 49.049.0 0.000050.00005 CO 25.7 26.126.1 0.000010.00001

COCO22 6.5 7.5 0.03140.0314

OO22 2.9 3.0 20.947620.9476 NN11.4.42.3 78.08478.084

CC22HH22 3.6 4.1 ----

CHCH44 2.8 2.5 0.00020.0002 MiscMisc22 6.06.0 5.6 ----

1 - Measured in mole percent 2 - Acetylene, Propane, C3 Olefin, Isobutane, nn--Butane,Butane, C4 Alkene, C5 Hydrocarbon ** Munro et al. JAAGL Nov 2001

Monitoring Venous Air Cervical Stenosis EmbolismEmbolism Sensitivity  Doppler, TE echo 0.1 -0.25- 0.25  Pabuccu R et al JMIG 2005 mL/Kg/min  End title CO2 or .025 -0.5- 0.5 – Hysteroscopic shaving for cervical Nitrogen tension air entrapment stenosisstenosis  CVP and Pulmonary .050505 - 0750750.75 artery P increase  3 patients, 3 pregnancies  Mean Art P decrease 0.75 -1.25- 1.25  Ventricular dysrhythmias1.25  MillMill--wheelwheel murmur1.5  Cardiovascular collapse 2.0

Operative Office Standard Hysteroscopy Hysteroscopy

 Standard Approach ––SpeculumSpeculum –preferable side opening – Tenaculum  Vaginoscopic approach – No speculum or tenaculum – Bettocchi S, Selvaggi L. A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc 1997;4:255-1997;4:255-8.8. – Cicinelli E, Parisi C, GaGalalantinontino P, Pinto V, Barba B, Schonauer S. Reliability, feasibility, and safety of minihysteroscopy with a vaginoscopic approach: experience with 6,000 cases. Fertil Steril 2003;80:19980:199--202202

56 Vaginoscopie : Technique Office Hysteroscopic procedures

 Diagnostic Hysteroscopy  Visually directed endometrial biopsy  Polypectomy  Myomectomy 12  Adhesiolysis  Metroplasty  Proximal tubal recanalization

Test questions Test Question

11 Congenital anomalies that affect 22 Hysterscopic adhesiolysis must be fertility include performed under laparoscopic a)a) Uterine Septum ggpuidance to avoid uterine perforation b) Uterine Didelphys a) True c) Vaginal septum b) False d) Uterine fibroids

Test question Test question

 Hysteroscopic myomectomy increases  Methods proven to prevent recurrence the risk of uterine rupture during of intrauterine adhesions include ppgregnancyp y a)a) Estrogen therapy ––TrueTrue b) Foley catheter in the uterine cavity ––FalseFalse c) Post op adhesiolysis d) Soy products e) IUD

57 Does Treating Endometriosis Disclosures Improve Fertility? Grants/Research Support: Auxogyn, Bayer‐Sherring, EMD‐Serono Consultant: LabCorp AAGL 41st Global Congress Other: CEO and Founder ‐ Advanced Reproductive Care November 6, 2012

David Adamson, MD Director, Fertility Physicians of Northern California Adjunct Clinical Professor, Stanford University Associate Clinical Professor, UCSF

Learning Objectives Treatment Options • Describe the role of observation, ovarian • Observation/Symptomatic stimulation, ovarian suppression, surgery and • Surgery combined treatments. • Medical Treatments • List the clinical indications for performing ART. – Ovarian Suppression – Combined suppression and surgery • Explain confounding variables affecting management of endometriomas. – Intrauterine insemination (IUI) – Controlled Ovarian Stimulation (COS) • Assisted Reproductive Technologies (ART)

SURGERY

Adamson, Frison & Lamb. The effect of pelvic endometriosis on fertility. Presented: Pacific Coast Fertility Society Annual Meeting. Oct 1979. Published: Fertil Steril. 1982 Dec;38(6):659-66.

58 Appearance Changes With Age Disease Progression in Infertility Appearance Mean Age Age Range • Laparoscopy for unexplained infertility – Patients with normal pelvis Clear only 21.5 17-26 • Those negative not preg repeat L/S 2 years Red only 26.3 16-38 – 20% macrosco pic endometriosis

White only 29.5 20-39 Pepperell and McBain, Br J OG 1985: 92; 569‐580 Sutton, Fertil Steril. 1997;68(6): 1070–1074. Black only 31.9 20-52

Infertility Outcomes: Surgery Surgical Treatment • Minimal/Mild Disease of Minimal Endo – Controversial for many years – Summary non‐randomized studies • 341 women surgery vs. no treatment 58% vs. 45% • Stage I‐II – Fecundity not different 6‐7% • 36 week follow‐up – Endocan RCT(()NNT 7.7) 37.5% vs. 22.5% – Gruppo Italiano RCT 19.6% vs. 22.2% • Pregnancy rates – Combined Endocan/Italy OR 1.66 (1.09‐2.51) – 31% vs. 18% – Cochrane: laparoscopy may improve PR (1) – Italian 29 vs 24% – ESHRE, RCOG (A level 1a):ablation/lysis effective (2,3) (1) Jacobson. Cochrane Database Syst Rev. 2002;(4):CD001398. – OR 1.7 (2) ESHRE guidelines. Hum Reprod 2005;20:2698‐704. Vercellini, Hum Reprod 2009;24(2): 254-69. (3) RCOG. Guideline No XX. 2005.

Infertility Outcomes: Surgery Pregnancy Rates Following Surgical Excision: Negative Correlation With Stage • Moderate/Severe Disease – Severe anatomic distortion CPR Ref Stage of Endometriosis P‐value – Very low background pregnancy rate – Numerous uncontrolled trials show benefit Min Mild Mod Sev – L/S > laparotomy: RR 1.87; p=0.031 (1) – Surgery indicated for invasive, adhesive, cystic 1 year Guzick 39% 31% 30% 25% NS endometriosis (Evidence level 3) (2,3) – Conservative surgical therapy with laparoscopy 1 year Adamson 45%‐‐ ‐‐32%‐‐ NS and possible laparotomy are indicated. (4) (1) Adamson. Fertil Steril 1993;59(1):35‐44. (2) RCOG Guideline No XX. 2005. (3) ESHRE guidelines. Hum Reprod 2005;20:2698‐704. 1.5 years Osuga ‐‐45%‐‐ ‐‐28%‐‐ <0.05 (4) ASRM Practice Committee. Fertil Steril 2006;86(Suppl4):S156‐60. D’Hooge. Sem Reprod Med 2003;21:243‐53.

59 Endometrioma Treatment Endometriomas • Cyst >5 cm (? Endometrioma) – According to protocol • Endometriomas Size to treat – Unknown – ? > 3‐4 cm • Technique – Stripping preferred where possible (1, 2) • Lower recurrence rate – Drainage and coagulation (3) • Avoid damage to normal ovarian tissue – Potentially greater with stripping (1) Hart. Cochrane Syst. Rev. 2008 Apr 16;(2):CD004992. (2) Pellicano. Fertil Steril 2008;89:796‐9. (3) Vercellini. Am J Obstet Gynecol. 2003 Mar;188(3):606‐10.

Complete Posterior Cul‐de‐sac ESHRE Guidelines Obliteration and DIE Estimated Life Table Pregnancy Rates (1) • Insufficient evidence whether surgical excision of % Pregnant Laparoscopy Laparotomy moderate‐severe disease enhances pregnancy rates (1‐3) 1 Year 29.6 ± 14.4 0 ± 0.0 • Probable negative correlation between stage of endometriosis and pregnancy rate after surgical 2 Years 29.6 ± 14.4 23.7 ± 12.2 removal (4) • No clarity as to best surgical approach (2,3) BRESLOW p=0.084 (1) Adamson et al. Fertil Steril1993;59:35‐44. • Complication rates 0-13% (3) (2) Guzick et al. Fertil Steril 1997;67;822‐9. (1) Adamson. Lasers Surg Med Suppl. 1992;4:1-85. (3) Osuga et al. Gynecol Obstet Invest 2002;53(Suppl 1), 33‐9. (2) Vercellini . Am J Obstet Gynecol 2006 Nov;195(5):1303-10. (3) Vercellini. Hum Reprod 2009 Oct;24(10):2504-14. (4) Kennedy (ESHRE). Hum Reprod 2005;20:2698‐704.

Fecundity (f) Following Surgical Techniques Treatment of Endometriosis • Minimize number of surgeries (1) 5.0 • Use least invasive approach: laparoscopy (1) 4.0 • Minimize tissue trauma (1) • Remove all disease (no RCT proof) 3.0 Month 1-3 Month 4-6 Monthly • Consider adhesion barrier(1) 202.0 Month 7 -9 f (%) – No evidence on any benefit of improving Month 10-12 pregnancy outcomes (2,3) 1.0 (1) Robertson. J Obstet Gynaecol Can. 2010 Jun;32(6):598‐608. 0.0 (2) Metwally. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD001298. Year 1 Year 2 Year 3 (3) Ahmad. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000475. f2=2.9% f3=0.6%

f1=4.4%

Adamson et al. Fertil Steril. 1993;59(1):35-44.

60 Conclusion • Endometriosis Fertility Index (EFI) – Simple, robust and validated clinical tool – Predicts pregnancy rates for patients following surgical staging of endometriosis – Very useful in developing treatment plans for infertile endometriosis patients • Prospective validation by other clinicians should

Adamson. Fertil Steril encourage widespread application of the EFI to 2010;94(5):1609-15. benefit patients

Ovarian Suppression For Fertility • No evidence of fertility benefit from ovarian suppression: 25 RCTs (1) MEDICAL TREATMENTS – Costs and delay time to pregnancy • GnRHa treatment before IUI is not recommenddded OVARIAN SUPPRESSION – 1 RCT suggesting benefit IVF and IUI IUI – Insufficient evidence to determine benefit in IUI alone (2) COS (1) Hughes. Cochrane Syst Rev 2007 Jul 18;(3):CD000155. (2) Rickes. Fertil Steril 2002;78(4):757‐62.

Meta-analysis: Surgery Better AND Suppression Not Helpful Infertility Outcomes: Ovarian Suppression and Surgery • Adjunct to Surgery (16 RCTs) – Preoperative • No data conclusively show benefit (1) – Postoperative • No data show benefit (1) • Does not improve fert ility (A. Level 1b)(2,3) • Delay in attempting pregnancy, costs, side effects render ovarian suppression not appropriate (1) Yap. Cochrane Database Syst Rev. 2004;(3):CD003678. (2) ESHRE guidelines. Hum Reprod 2005;20:2698‐704. (3) RCOG. Guideline No XX. 2005.

Adamson et al. Am J Obstet Gynecol. 1994;171(6):1488-505.

61 Endometriosis Treatment IUI +/‐ COS Stage I and II • IUI with COS effective in improving fertility in minimal/mild endometriosis (1,2)

COS + IUI Appropriate BEFORE Laparoscopy • Role of unstimulated IUI is uncertain (2) • Double insemination should be considered (3)

(1) Tummon. Fertil Steril 1997;68(1):8‐12. (2) Costello. Aust NZ J Obstet Gynaecol 2004;44(2):93‐102. (3) Subit. Am J Reprod Immunol 2011 Aug;66(2):100‐7.

COS + IUI Appropriate BEFORE Laparoscopy

Laparoscopy Prior to IUI/COS When To Do Laparoscopy? • Younger women (?<37 years of age) • Insufficient data to recommend laparoscopic • Short duration of infertility (<4 years) surgery prior to IUI/COS • Normal male factor • Normal or treatable uterus • Unless • Normal ovulation, or • Easily treatable ovulation disorder – History • Limited prior treatment – Evidence of anatomic disease • Appropriate candidate for laparoscopy – “Treatable” disease reasonably suspected (NNT) – Sufficient to justify the physical, emotional, – OR= 1.66 (1) financial and time costs – No contraindications to laparoscopy (1) Tanahatoe. Fertil Steril 2003;79(2):361‐6. – Patient accepts 9‐15 months attempting before IVF (1) Jacobson. IVF Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001398. (2) Tanahatoe. Hum Reprod 2005;20(11):3225‐30. (2) ASRM Practice Committee. Fertil Steril. 2006;86(Suppl 4):S156‐60.

Impact of Endometriosis Stage on IVF Outcomes • Only observational studies for ART (e.g. Rosenwaks 2002; Barnhart 2002) ENDOMETRIOSIS • With laparoscopic retrieval, probably yes • With transvaginal retrieval, pyprobably no • No studies have had sufficient power to AND IVF evaluate the impact of extensive disease (AFS Score >71) (1) • IVF PR lower in endometriosis (Level 1a) (2) (1) Guzick et al. Fertil Steril 1997;67:822‐9. (2) ESHRE guidelines. Hum Reprod 2005;20:2698‐704.

62 IVF and Endometriosis Role of IVF in Endometriosis • For women with stage III/IV endometriosis who • fail to conceive following conservative surgery or Although IVF may be less effective for IVF because of advancing reproductive age, IVF is an than for other causes of infertility, it should effective alternative (1) be considered for use to improve the success • IVF is appro priate treatment esppyecially if tubal rate above expectant management. function is compromised, if there is also male factor infertility, and /or other treatments have (1) Barnhart. Fertil Steril 2002;77:1148‐55. failed (Level IIb) (2,3) (2) Benschop. Cochrane Syst. Rev. 2010;11:CD008571. (1) ASRM Practice Committee. Fertil Steril 2006;86(Suppl 4):S156‐60. (3) Soliman.1993 Jun;59(6):1239‐44. (4) De Hondt. Curr Opin Obstet Gynecol 2006 Aug;18(4):374‐9 (2) RCOG. Guideline No XX. 2005. (3) ESHRE guidelines. Hum Reprod 2005;20:2698‐704.

Endometriomas and Endometriosis Role of Ovarian Suppression Before Before IVF IVF • No RCT’s with adequate controls • Laparoscopy for >4 cm endometriomas (GPP) (1‐3) – Generally not helpful for infertility – Confirm histologic diagnosis – Does not improve endometriomas – Reduce risk of infection • Some data suggesting improved pregnancy rates when suppression precedes IVF (1‐3) – Improve access to follicles – GnRHa for 3‐6 months increases PR 4X (A. Level 1a) (3,4) – Possibly improve ovarian response – Prolonged treatment with GnRHa in mod/severe should be considered because improved pregnancy rates have been • EliExplain riiksk of poor ovar ian response post‐op reported (A. Level 1b)(5) • Reconsider decision if previous ovarian surgery – Optimal duration of treatment unknown (range 2‐26 weeks) • No evidence of benefit of surgery for endometriosis – Our practice treats additional 4‐12 weeks for moderate/severe endometriosis before IVF (4) • No data on oral contraceptives (1) RCOG. Guideline No XX. 2005. (1) Rickes. Fertil Steril 2002;78:757‐62. (2) Kennedy (ESHRE). Hum Reprod 2005;10:2698‐704. (2) Surrey. Fertil Steril 2002;78:699‐704. (3) Hart (Cochrane). Hum Reprod 2005;20:3000‐7. (3) Sallam. Cochrane Database Syst.Rev. 2006 Jan (4) Benschop. Cochrane Syst. Rev. 2010 Nov 10;(11):CD008571. 25;(1):CD004635. (4) RCOG. Guideline No XX. 2005 (5)ESHRE guidelines. Hum Reprod 2005;20:2698‐704.

Endometrioma Treatment Failed IVF Treatment Endo Before ART • 4 Trials; n=312

• GnRHa vs. GnRH antagonist • CPR: No difference • NMOR and Ovarian Response: GnRHa > Antagonist

•Surggy(pery (Aspiration or C ystectom y) vs. Ex pectant Mana gement • CPR: No difference • NMOR and Ovarian Response: Aspiration > Expectant • Cystectomy vs. Expectant • COS response less with cystectomy • Aspiration versus cystectomy • CPR and NMOR: No difference Benschop. http://summaries.cochrane.org/CD008571. Accessed Sep 23, 2012.

63 Management Summary (1) • Pelvic Pain – Initially analgesics, NSAID’s, OC’s • Infertility with other factors normal – CC 100mg CD 3‐7 + IUI for 3‐6 cycles, SUMMARY ddidepending on age – Other ovarian stimulation regimen • Persistence of pain and/or infertility without other significant infertility factors – Laparoscopy, diagnostic & operative

Management Summary (2) • Surgery well performed is effective treatment – All stages endometriosis & endometriomas – Infertility and Pain • Ovarian suppression generally effective for pain • Repeat surgery – Limited benefit for fertility, some for pain THANK • Pre‐IVF treatment ONLY – SiSuppression: reasonable extitensive disease – Surgery: ? large > 3‐4 cm endometriomas • Endometriosis NO effect on IVF LBR except YOU! – Extensive disease +/or endometriomas (1) Adamson et al. Am J Obstet Gynecol. 1994;171(6):1488‐505. (2) Adamson. Fertil Steril 2005;84(6):1582‐4. (3) Adamson GD. Modern Management Endometriosis 2006:289‐305. (4) ASRM Practice Committee. Fertil Steril. 2006;86(Suppl 4):S156‐60.

References References Adamson. Am J Obstet Gynecol. 1994;171(6):1488‐505. Adamson. Fertil Steril 1982 Dec; 38(6):659‐66. Adamson. Fertil Steril 1993; 59(1):35‐44. Adamson. Fertil Steril 2005; 84(6):1582‐4. Adamson. Fertil Steril 2010; 94(5):1609‐15. Pellicano. Fertil Steril 2008; 89:796‐9. Adamson. Lasers Surg Med Suppl. 1992; 4:1‐85. Pepperell and McBain, Br J OG 1985: 92; 569‐80. Adamson. Modern Management Endometriosis 2006:289‐305. RCOG Guideline No XX. 2005. Ahmad. Cochrane Database Syst Rev.r 20 08 Ap 16;(2):CD000475. Rickes. Fertil Steril 2002;78(4):757‐62. ASRM Practice Committee. Fertil Steril 2006; 86(Suppl4):S156‐60. Robertson. J Obstet Gynaecol Can. 2010 Jun;32(6):598‐608. ASRM Practice Committee. Fertil Steril. 2006;86(Suppl 4):S156‐60. Sallam. Cochrane Database Syst.Rev. 2006 Jan 25;(1):CD004635. Barnhart. Fertil Steril 2002;77:1148‐55. Soliman.1993 Jun;59(6):1239‐44. Benschop. Cochrane Syst. Rev. 2010;11:CD008571. Subit. Am J Reprod Immunol 2011 Aug; 66(2):100‐7. Costello. Aust NZ J Obstet Gynaecol 2004; 44(2):93‐102. Surrey. Fertil Steril 2002; 78:699‐704. D’Hooge. Sem Reprod Med 2003; 21: 243‐53. Sutton, Fertil Steril. 1997; 68(6): 1070–4. De Hondt. Curr Opin Obstet Gynecol 2006 Aug;18(4):374‐9. Tanahatoe. Fertil Steril 2003; 79(2):361‐6. ESHRE guidelines. Hum Reprod 2005; 20:2698‐704. Tanahatoe. Hum Reprod 2005; 20(11):3225‐30. Guzick et al. Fertil Steril 1997; 67;822‐9. Tummon. Fertil Steril 1997; 68(1):8‐12. Hart. Cochrane Syst Rev. Hum Reprod 2005;20:3000‐7. Vercellini. Am J Obstet Gynecol 2003 Mar; 188(3):606‐10. Hart. Cochrane Syst. Rev. 2008 Apr 16; (2):CD004992. Vercellini. Am J Obstet Gynecol 2006 Nov; 195(5):1303‐10. Hughes. Cochrane Syst Rev 2007 Jul 18;(3):CD000155. Vercellini. Hum Reprod 2009; 24(10):2504‐14. Jacobson. Cochrane Database Syst Rev. 2002; (4):CD001398. Vercellini. Hum Reprod 2009; 24(2): 254‐69. Jacobson. IVF Cochrane Database Syst Rev. 2010 Jan 20; (1):CD001398. Yap. Cochrane Database Syst Rev. 2004; (3):CD003678. Kennedy (ESHRE). Hum Reprod 2005; 20: 2698‐704. Littman. Fertil Steril 2005. Metwally. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD001298. Osuga et al. Gynecol Obstet Invest 2002; 53(Suppl 1), 33‐9.

64 CULTURAL AND LINGUISTIC COMPETENCY

Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians (researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

US Population California Language Spoken at Home Language Spoken at Home

Spanish English Spanish

Indo-Euro English Indo-Euro Asian Other Asian

Other 19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the program, the importance of the services, and the resources available to the recipient, including the mix of oral and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies, including those which provide federal financial assistance, to examine the services they provide, identify any need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every California state agency which either provides information to, or has contact with, the public to provide bilingual interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

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If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills. A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

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