The Effects of Different Gonadotropin Releasing Hormone Analogues in IVF Cycles
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Hormones and Breeding
IN-DEPTH: REPRODUCTIVE ENDOCRINOLOGY Hormones and Breeding Carlos R.F. Pinto, MedVet, PhD, Diplomate ACT Author’s address: Theriogenology and Reproductive Medicine, Department of Veterinary Clinical Sciences, College of Veterinary Medicine, The Ohio State University, Columbus, OH 43210; e-mail: [email protected]. © 2013 AAEP. 1. Introduction affected by PGF treatment to induce estrus. In The administration of hormones to mares during other words, once luteolysis takes place, whether breeding management is an essential tool for equine induced by PGF treatment or occurring naturally, practitioners. Proper and timely administration of the events that follow (estrus behavior, ovulation specific hormones to broodmares may be targeted to and fertility) are essentially similar or minimally prevent reproductive disorders, to serve as an aid to affected (eg, decreased signs of behavioral estrus). treating reproductive disorders or hormonal imbal- Duration of diestrus and interovulatory intervals ances, and to optimize reproductive efficiency, for are shortened after PGF administration.1 The example, through induction of estrus or ovulation. equine corpus luteum (CL) is responsive to PGF These hormones, when administered exogenously, luteolytic effects any day after ovulation; however, act to control the duration and onset of the different only CL Ͼ5 days are responsive to one bolus injec- stages of the estrous cycle, specifically by affecting tion of PGF.2,3 Luteolysis or antiluteogenesis can duration of luteal function, hastening ovulation es- be reliably achieved in CL Ͻ5 days only if multiple pecially for timed artificial insemination and stimu- PGF treatments are administered. For that rea- lating myometrial activity in mares susceptible to or son, it became a widespread practice to administer showing delayed uterine clearance. -
Hertfordshire Medicines Management Committee (Hmmc) Nafarelin for Endometriosis Amber Initiation – Recommended for Restricted Use
HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) NAFARELIN FOR ENDOMETRIOSIS AMBER INITIATION – RECOMMENDED FOR RESTRICTED USE Name: What it is Indication Date Decision NICE / SMC generic decision status Guidance (trade) last revised Nafarelin A potent agonistic The hormonal December Final NICE NG73 2mg/ml analogue of management of 2020 Nasal Spray gonadotrophin endometriosis, (Synarel®) releasing hormone including pain relief and (GnRH) reduction of endometriotic lesions HMMC recommendation: Amber initiation across Hertfordshire (i.e. suitable for primary care prescribing after specialist initiation) as an option in endometriosis Background Information: Gonadorelin analogues (or gonadotrophin-releasing hormone agonists [GnRHas]) include buserelin, goserelin, leuprorelin, nafarelin and triptorelin. The current HMMC decision recommends triptorelin as Decapeptyl SR® injection as the gonadorelin analogue of choice within licensed indications (which include endometriosis) link to decision. A request was made by ENHT to use nafarelin nasal spray as an alternative to triptorelin intramuscular injection during the COVID-19 pandemic. The hospital would provide initial 1 month supply, then GPs would continue for further 5 months as an alternative to the patient attending for further clinic appointments for administration of triptorelin. Previously at ENHT, triptorelin was the only gonadorelin analogue on formulary for gynaecological indications. At WHHT buserelin nasal spray 150mcg/dose is RED (hospital only) for infertility & endometriosis indications. Nafarelin nasal spray 2mg/ml is licensed for: . The hormonal management of endometriosis, including pain relief and reduction of endometriotic lesions. Use in controlled ovarian stimulation programmes prior to in-vitro fertilisation, under the supervision of an infertility specialist. Use of nafarelin in endometriosis aims to induce chronic pituitary desensitisation, which gives a menopause-like state maintained over many months. -
Nafarelin Acetate (Synarel) Reference Number: PA.CP.PHAR.174 Effective Date: 01/18 Coding Implications Last Review Date: 10/18 Revision Log
Clinical Policy: Nafarelin Acetate (Synarel) Reference Number: PA.CP.PHAR.174 Effective Date: 01/18 Coding Implications Last Review Date: 10/18 Revision Log Description The intent of the criteria is to ensure that patients follow selection elements established by Pennsylvania Health and Wellness® medical policy for the use of nafarelin acetate (Synarel®). FDA Approved Indication(s) Synarel is indicated for: • Treatment of CPP (gonadotropin-dependent precocious puberty) in children of both sexes; • Management of endometriosis, including pain relief and reduction of endometriotic lesions. Policy/Criteria It is the policy of Pennsylvania Health and Wellness that Synarel is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Central Precocious Puberty (must meet all): 1. Diagnosis of central precocious puberty confirmed by all of the following (a through c): a. Elevated basal luteinizing hormone (LH) level > 0.2 - 0.3 mIU/L (dependent on type of assay used) and/or elevated leuprolide-stimulated LH level > 3.3 - 5 IU/I (dependent on type of assay used); b. Difference between bone age and chronological age was > 1 year (bone age- chronological age; c. Age at onset of secondary sex characteristics is < 8 years if female, or < 9 years if male; 2. Member meets the following age requirements: a. Female: 2 - 11 years; b. Male: 2 - 12 years; 3. Prescribed by or in consultation with a pediatric endocrinologist; 4. Dose does not exceed 1800 micrograms per day. Approval duration: 12 months B. Endometriosis (must meet all): 1. Diagnosis of endometriosis; 2. Prescribed by or in consultation with a gynecologist; 3. -
Degarelix for Treating Advanced Hormone- Dependent Prostate Cancer
CONFIDENTIAL UNTIL PUBLISHED NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Final appraisal determination Degarelix for treating advanced hormone- dependent prostate cancer This guidance was developed using the single technology appraisal (STA) process 1 Guidance 1.1 Degarelix is recommended as an option for treating advanced hormone-dependent prostate cancer, only in adults with spinal metastases who present with signs or symptoms of spinal cord compression. 1.2 People currently receiving treatment initiated within the NHS with degarelix that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. 2 The technology 2.1 Degarelix (Firmagon, Ferring Pharmaceuticals) is a selective gonadotrophin-releasing hormone antagonist that reduces the release of gonadotrophins by the pituitary, which in turn reduces the secretion of testosterone by the testes. Gonadotrophin- releasing hormone is also known as luteinising hormone-releasing hormone (LHRH). Because gonadotrophin-releasing hormone antagonists do not produce a rise in hormone levels at the start of treatment, there is no initial testosterone surge or tumour stimulation, and therefore no potential for symptomatic flares. National Institute for Health and Care Excellence Page 1 of 71 Final appraisal determination – Degarelix for treating advanced hormone-dependent prostate cancer Issue date: April 2014 CONFIDENTIAL UNTIL PUBLISHED Degarelix has a UK marketing authorisation for the ‘treatment of adult male patients with advanced hormone-dependent prostate cancer’. It is administered as a subcutaneous injection. 2.2 The most common adverse reactions with degarelix are related to the effects of testosterone suppression, including hot flushes and weight increase, or injection site reactions (such as pain and erythema). -
Nafarelin Acetate (Synarel) Reference Number: CP.PHAR.174 Effective Date: 02/16 Coding Implications Last Review Date: 02/17 Revision Log
Clinical Policy: Nafarelin Acetate (Synarel) Reference Number: CP.PHAR.174 Effective Date: 02/16 Coding Implications Last Review Date: 02/17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The intent of the criteria is to ensure that patients follow selection elements established by Centene® medical policy for the use of nafarelin acetate (Synarel®). Policy/Criteria It is the policy of health plans affiliated with Centene Corporation® that Synarel is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Central Precocious Puberty (must meet all): 1. Females age ≤ 11 years or males ≤ 12 years; 2. Diagnosis of central precocious puberty (CPP) confirmed by (a through c): a. Elevated basal luteinizing hormone (LH) level > 0.2 - 0.3 mIU/L (dependent on type of assay used) and/or elevated leuprolide-stimulated LH level > 3.3 - 5 IU/I (dependent on type of assay used); b. Bone age ≥ 1 year advanced of chronological age; c. Age at onset of secondary sex characteristics is < 8 years, if female, or < 9 years, if male; 3. Prescribed dose of Synarel does not exceed 1800 micrograms/day administered as 600 micrograms three times a day; 4. Member has none of the following contraindications: a. Known hypersensitivity to gonadotropin-releasing hormone (GnRH), GnRH analogs, or any excipient in the requested product; b. If female, pregnancy. Approval duration: 12 months B. Endometriosis or Chronic Refractory Pelvic Pain (must meet all): 1. Diagnosis of one of the following: a. Endometriosis (i or ii): i. Diagnosis surgically confirmed; ii. -
Altered Cognitive Function in Men Treated for Prostate
Altered Cognitive Function in Men Treated for Prostate Cancer with LHRH Analogues and Cyproterone Acetate: A Randomised Controlled Trial H. J. Green PhD1,2, K. I. Pakenham PhD1, B. C. Headley PhD3, J. Yaxley FRACS3, D. L. Nicol FRACS2,4, P. N. Mactaggart FRACS2,5, C. Swanson PhD2, R. B. W atson FRACS6, & R. A. Gardiner MD2,3 1School of Psychology and 2Department of Surgery, The University of Queensland, 3Royal Brisbane, 4Princess Alexandra, 5Queen Elizabeth II & 6Mater Hospitals, Brisbane, Queensland, Australia In conjunction with the Northern Section of the Urological Society of Australasia Correspondence should be addressed to: Dr R. A. Gardiner, Department of Surgery, The University of Queensland, Brisbane, Qld 4072, Australia Fax: +61 7 3365 5559; Phone: +61 7 3365 5233; Email: f.gardiner@ mailbox.uq.edu.au This work was wholly funded by Queensland Cancer Fund. **PREPRINT. Final version published in British Journal of Urology (BJU: International) (2002), 90, 427-432 ** Short Title: COGNITIVE CHANGES W ITH HORMONAL MEDICATION 2 Objective. Luteinising hormone releasing hormone (LHRH) analogues have been associated with memory impairments in women using these drugs for gynaecological conditions. This is the first systematic investigation of the cognitive effects of LHRH analogues in male patients. Methods. 82 men with non-localised prostate cancer were randomly assigned to receive continuous leuprorelin (LHRH analogue), goserelin (LHRH analogue), cyproterone acetate (steroidal antiandrogen) or close clinical monitoring. These patients underwent cognitive assessments at baseline and before commencement of treatment (77) then 6 months later (65). Results. Compared with baseline assessments, men administered androgen suppression monotherapy performed worse in 2/12 tests of attention and memory. -
The Use of an Intravaginal Triptorelin Gel to Induce Ovulation in the Mare
THE USE OF AN INTRAVAGINAL TRIPTORELIN GEL TO INDUCE OVULATION IN THE MARE by CHELSEA D. SINCLAIR B.S., Clemson University, 2013 A THESIS submitted in partial fulfillment of the requirements for the degree MASTER OF SCIENCE Department of Animal Sciences and Industry College of Agriculture KANSAS STATE UNIVERSITY Manhattan, Kansas 2016 Approved by: Major Professor Dr. Joann M. Kouba Copyright CHELSEA D. SINCLAIR 2016 Abstract The objective of these studies was to investigate the efficacy of an intravaginal triptorelin acetate (TA) gel as an ovulation-inducing agent in mares. In Exp 1, 24 mares were stratified by parity and age and randomly assigned to 3 treatment groups receiving either: 5 mL TA gel (500 μg TA; TA5), 10 mL TA gel (1,000 μg TA; TA10), or 5 mL vehicle gel only (CON). Following the appearance of a follicle ≥ 25 mm, blood samples were obtained every 24 h until treatment administration for measurement of luteinizing hormone (LH) concentrations. Once a follicle ≥ 35 mm in diameter was detected, treatment was administered intravaginally. Following treatment, blood samples were collected and ovaries were scanned via transrectal ultrasonography every 12 h until 48 h post-ovulation. Both TA5 and TA10 tended (P = 0.08) to experience a brief surge in LH by 12 h post-treatment. Regarding LH concentrations, there was a significant (P < 0.005) treatment by time interaction. The interval from treatment to ovulation was not different (P > 0.05) between groups, nor was there a difference (P > 0.05) in the percentage of mares ovulating within 48 h of treatment administration. -
Triptorelin, Goserelin and Leuprorelin for Prostate
789FM.1 GONADORELIN ANALOGUES (GnRHa): TRIPTORELIN, GOSERELIN, LEUPRORELIN FOR PROSTATE CANCER - AMBER RECOMMENDATION GUIDELINE This guideline provides prescribing and monitoring guidance for triptorelin, goserelin and Leuprorelin use in prostate cancer. It should be read in conjunction with the Summary of Product Characteristics (SPC), available on www.medicines.org.uk/emc, and the BNF. BACKGROUND AND INDICATIONS FOR USE There is no conclusive evidence to suggest that any one GnRHa is more effective or has fewer side effects than another for the treatment of prostate cancer.5, 7-9 Available evidence suggests that GnRHa are similar in effectiveness to surgical castration. They have the same licensed indications in the treatment of prostate cancer (Appendix 1). Appendix 2 compares doses, administration frequency and costs.1-4, 9-13 Triptorelin 22.5 mg (six monthly injection) is the 1st choice GnRHa for treatment of metastatic prostate cancer patients on life-long treatment on the Bucks formulary. This is because it is: • Administered via a smaller sized needle (20 gauge) compared to goserelin LA 10.8 mg (14 gauge), thus minimising discomfort to patients.9 • The least expensive in terms of drug and administration costs (Appendix 2).1-4, 9-13 Triptorelin 22.5 mg (six monthly injection) is not preferred in: • Patients newly initiated GnRHa because the first dose should be a monthly preparation (Decapeptyl® SR 3 mg) in order to check that the product is tolerated prior to changing to the six monthly preparation.14 • Anticoagulated patients. This is because triptorelin is an intramuscular (IM) injection. Subcutaneously administered GnRHa (goserelin or leuprorelin) may be preferable.9 RESPONSIBILITIES Hospital specialist 1. -
Luteal Support with Very Low Daily Dose of Human Chorionic Gonadotropin After Fresh Embryo Transfer As an Alternative to Cycle S
pharmaceuticals Article Luteal Support with very Low Daily Dose of Human Chorionic Gonadotropin after Fresh Embryo Transfer as an Alternative to Cycle Segmentation for High Responders Patients Undergoing Gonadotropin-Releasing Hormone Agonist-Triggered IVF Andrea Roberto Carosso 1,*,† , Stefano Canosa 1,† , Gianluca Gennarelli 1 , Marta Sestero 1, Bernadette Evangelisti 1, Lorena Charrier 2 , Loredana Bergandi 3 , Chiara Benedetto 1,‡ and Alberto Revelli 1,‡ 1 Obstetrics and Gynecology 1U, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, Sant’Anna Hospital, University of Torino, 10042 Turin, Italy; [email protected] (S.C.); [email protected] (G.G.); [email protected] (M.S.); [email protected] (B.E.); [email protected] (C.B.); [email protected] (A.R.) 2 Department of Public Health and Pediatrics, University of Torino, Via Santena, 5 bis, 10126 Torino, Italy; [email protected] 3 Department of Oncology, University of Torino, Via Santena 5 bis, 10126 Torino, Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-333-8111155 or +39-011-3135763 † These authors contributed equally to this work. Citation: Carosso, A.R.; Canosa, S.; ‡ These authors jointly supervised this work. Gennarelli, G.; Sestero, M.; Evangelisti, B.; Charrier, L.; Bergandi, Abstract: The segmentation of the in vitro fertilization (IVF) cycle, consisting of the freezing of L.; Benedetto, C.; Revelli, A. Luteal all embryos and the postponement of embryo transfer (ET), has become popular in recent years, Support with very Low Daily Dose of Human Chorionic Gonadotropin after with the main purpose of preventing ovarian hyperstimulation syndrome (OHSS) in patients with Fresh Embryo Transfer as an high response to controlled ovarian stimulation (COS). -
Comparison of Oocyte Maturity Rates in Recombinant Human Chorionic Go
International Journal of ISSN 2692-5877 Clinical Studies & Medical Case Reports DOI: 10.46998/IJCMCR.2020.07.000150 Research Article Comparison of Oocyte Maturity Rates in Recombinant Human Chorionic Go- nadotrophin (HCG) and Triptorelin Acetate Triggers; A Prospective Randomised Study Lakshmanan S1, Saravanan M1, Senthil P1* and Sharma N2 1ARC International Fertility Center, 947, Avinashi Road, Puliakulam, Coimbatore, 641037, Tamilnadu, India 2Department of Obstetrics and Gynecology, Saveetha University, Kuthambaakam, Chennai-600124, Tamil Nadu, India *Corresponding author: Priya Senthil, ARC International Fertility Center, 947, Avinashi Road, Puliakulam, Coim- batore, 641037, Tamilnadu, India. Tel: 8220812314; E-mail: [email protected] Received: September 16, 2020 Published:November 20, 2020 Abstract LH like exposure in the mid cycle for inducing the oocyte maturation, is the very crucial step in the success of ICSI treatment. Introduction of LH surge endogenously by GnRH-agonist for final oocyte maturation induction, may be more physiological compared with the administration of HCG. Since GnRH agonist would induce FSH surge also along with LH surge, as happens in natural cycle. However, the effects of giving HCG trigger for inducing only LH surge and giv- ing GnRH agonist trigger for inducing both LH and FSH surge, in patients treated for ICSI with GnRHantagonists need more research. Sub fertile patients planned for ICSI, meeting the requirement of inclusion criteria, were started with re- combinant FSH from day 2 of menstrual cycle. GnRH antagonists were started from day 6 of stimulation. FSH dose was adjusted according to the individual response. Trigger was planned when the lead follicle reaches 24 mm. For triggering, 100 patients were randomised to receive Recombinant HCG trigger and Triptorelin acetate trigger. -
Triptodur (Triptorelin)
Triptodur (triptorelin) (Intramuscular) Document Number: IC-0308 Last Review Date: 08/04/2020 Date of Origin: 08/01/2017 Dates Reviewed: 08/2017, 08/2018, 08/2019, 08/2020 I. Length of Authorization Coverage will be provided for 12 months and may be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [NDC Units]: • Triptodur 22.5 mg single-use kit: 1 kit per 168 days B. Max Units (per dose and over time) [HCPCS Units]: • 6 billable units per 168 days III. Initial Approval Criteria Coverage is provided in the following conditions: Central Precocious Puberty (CPP) † Ф 1,2-4,5 • Patient is between the ages of 2 and 13 years; AND • Onset of secondary sexual characteristics earlier than age 8 for girls and 9 for boys associated with pubertal pituitary gonadotropin activation; AND • Diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH; AND • Bone age advanced greater than 2 standard deviations (SD) beyond chronological age; AND • Tumor has been ruled out by lab tests such as diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), and human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor). † FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug Proprietary & Confidential © 2020 Magellan Health, Inc. 1 IV. Renewal Criteria Authorizations can be renewed based on the following criteria: • Patient continues to meet indication-specific relevant criteria identified in section III; ; AND • Absence of unacceptable toxicity from the drug. -
Nafarelin Acetate (Synarel) Reference Number: ERX.SPA.148 Effective Date: 10.01.16 Last Review Date: 11.17 Revision Log
Clinical Policy: Nafarelin Acetate (Synarel) Reference Number: ERX.SPA.148 Effective Date: 10.01.16 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Nafarelin acetate (Synarel®) is a gonadotropin-releasing hormone (GnRH) agonist. FDA Approved Indication(s) Synarel is indicated for: Treatment of central precocious puberty (CPP) in children of both sexes Management of endometriosis, including pain relief and reduction of endometriotic lesions Limitation(s) of use: Experience with Synarel for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months. Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Synarel is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Central Precocious Puberty (must meet all): 1. Diagnosis of CPP confirmed by (a through c): a. Elevated basal luteinizing hormone (LH) level > 0.2 - 0.3 mIU/L (dependent on type of assay used) and/or elevated leuprolide-stimulated LH level > 3.3 - 5 IU/I (dependent on type of assay used); b. Difference between bone age and chronological age was > 1 year (bone age- chronological age; c. Age at onset of secondary sex characteristics is < 8 years if female, or < 9 years if male; 2. Prescribed by or in consultation with a pediatric endocrinologist; 3. Member meets one of the following age requirements (a or b): a.