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Live Birth After in Vitro Maturation Versus Standard in Vitro

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Live Birth After in Vitro Maturation Versus Standard in Vitro Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-035334 on 14 April 2020. Downloaded from Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non- inferiority randomised clinical trial Xiaoying Zheng,1 Wei Guo,1 Lin Zeng ,2 Danni Zheng,1 Shuo Yang,1 Lina Wang,1 Rui Wang ,3 Ben W Mol,3 Rong Li,1 Jie Qiao 1 To cite: Zheng X, Guo W, ABSTRACT Strengths and limitations of this study Zeng L, et al. Live birth after Introduction Polycystic ovary syndrome (PCOS) is the in vitro maturation versus first common cause of anovulatory infertility. Currently, in ► This is a randomised controlled trial with an ade- standard in vitro fertilisation vitro fertilisation (IVF) is recommended when conventional for women with polycystic quate sample size to evaluate in vitro maturation attempts have failed. In vitro maturation (IVM) of human ovary syndrome: protocol for (IVM) treatment in infertile women with polycystic oocytes is an emerging treatment option in infertile women a non-inferiority randomised ovary syndrome. with PCOS. It is a patient- friendly intervention, avoiding clinical trial. BMJ Open ► This study will provide evidence on whether the ex- the risk of ovarian hyperstimulation syndrome, which is 2020;10:e035334. doi:10.1136/ perimental group (IVM) is non-inferior to the stan- a serious complication of controlled ovarian stimulation bmjopen-2019-035334 dard in vitro fertilisation in terms of live birth. in the standard IVF procedure. We plan a randomised ► Prepublication history for ► The cost- effective analysis is not included in the controlled trial (RCT) to evaluate whether IVM is non- this paper is available online. study, limiting the comprehensiveness of the results. To view these files, please visit inferior to the standard IVF for live birth in women with the journal online (http:// dx. doi. PCOS. org/ 10. 1136/ bmjopen- 2019- Methods and analysis This is a single- centre, open- 035334). label, non- inferiority RCT performed in a large reproductive intervention and ovulation induction with medicine centre in China. Infertile women with PCOS will letrozole or clomiphene citrate.3 Laparo- http://bmjopen.bmj.com/ XZ and WG are joint first be randomised to receive either IVM or standard IVF in a scopic ovarian drilling or ovarian induction authors. 1:1 treatment ratio after informed consent. IVF procedures used in our study are all standard treatments and other with gonadotrophin (Gn) is considered as the Received 28 October 2019 standard- assisted reproductive technologies will be similar second- line treatment options. In vitro fertil- Revised 30 January 2020 isation (IVF) is the third-line treatment and Accepted 12 March 2020 between the two groups. The primary outcome is ongoing pregnancy leading to live birth within 6 months of the is recommended when the above-mentioned first oocyte retrieval cycle after randomisation. Pregnancy treatments have failed. outcome, maternal safety and obstetric and perinatal In standard IVF treatment, women with on September 30, 2021 by guest. Protected copyright. complications will be secondary outcomes. The planned PCOS are at high risk of ovarian hyperstim- sample size is 350 (175 per group). © Author(s) (or their ulation syndrome (OHSS), which is a serious Ethics and dissemination Ethical permission was and common iatrogenic complication of employer(s)) 2020. Re- use acquired from the Ethics Committee of Peking University permitted under CC BY-NC. No controlled ovarian stimulation (COS). The Third Hospital. The results will be issued to publications commercial re- use. See rights prevalence of moderate and severe forms of and permissions. Published by through scientific journals and conference reports. BMJ. Trial registration number NCT03463772. OHSS in women undergoing IVF is 3%–8% 4 1Center for Reproductive and much higher in women with PCOS. Medicine, Department of Severe OHSS is defined by the presence Obstetrics and Gynecology, INTRODUCTION of clinical evidence of ascites with severe Peking University Third Hospital, Polycystic ovary syndrome (PCOS) is the first abdominal pain and pleural effusion. A large Beijing, China amount of pleural and peritoneal effusion 2Research Center of Clinical common cause of anovulatory infertility and Epidemiology, Peking University occurs in 5.6% in reproductive-aged women can lead to intravascular blood loss, blood 1 Third Hospital, Beijing, China in the Chinese communities . It is also a major concentration, blood hypercoagulability, 3OB/GYN, School of Medicine, metabolic disorder associated with insulin hypovolemic shock, severe cardiopulmonary Monash University, Melbourne, resistance, β-cell dysfunction and obesity.2 dysfunction, electrolyte imbalance, impaired Victoria, Australia Fifty per cent of women with PCOS present liver and kidney function, thrombosis and 5 Correspondence to with subfertility. In anovulatory women with even life- threatening. Therefore, seeking an Dr Jie Qiao; Jie. qiao@ 263. net PCOS, the first- line treatments are lifestyle alternative treatment strategy, avoiding the Zheng X, et al. BMJ Open 2020;10:e035334. doi:10.1136/bmjopen-2019-035334 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-035334 on 14 April 2020. Downloaded from risk of OHSS without compromising pregnancy outcomes ► Women with PCOS according to the revised is crucial for women with PCOS. Rotterdam criteria (ie, two of the three following In vitro maturation (IVM) has been introduced in features are present: (1) oligo and/or anovulation; 6 1990. Trounson et al described the first delivery of a (2) clinical and/or biochemical signs of hyperan- healthy baby with the IVM technique in a woman with drogenism; and (3) polycystic ovaries). Exclusion of PCOS. From then on, immature oocyte retrieval followed other possible related disorders: ovarian or adrenal by IVM had been used widely, resulting in the delivery of androgen- secreting tumours, thyroid disease, 7–9 thousands of healthy infants worldwide. In IVM, imma- hyperprolactinaemia, and non- classical adrenal ture oocytes are collected from antral follicles, typically hyperplasia.18 from unstimulated or minimally stimulated ovaries, then 10 ► Women scheduled for their first IVF/intracyto- cultured, matured and fertilised in vitro. Compared plasmic sperm injection (ICSI) cycle. Women must with standard IVF treatment, IVM is performed without have an indication for assisted reproductive tech- ovarian stimulation, thus preventing the occurrence of nology (ART), including ovulation dysfunction and OHSS and reducing financial costs. failure to become pregnant after ovulation induc- To date, despite the publication of many studies on tion treatment; unilateral or bilateral tubal obstruc- IVM, the effectiveness and safety of IVM treatment are tion, adhesion, salpingectomy or tubal ligation; and still controversial. Some studies showed that the live birth rate was significantly lower in the IVM group than in the oligoasthenozoospermia. IVF group.11–13 Now mature technology, gradually getting ► Written informed consent obtained. more research results, indicated comparable pregnancy Exclusion criteria outcomes between IVM and IVF group.14 15 Until now, all ► Couples with a contraindication for IVF or ICSI data available have derived from observational studies.16 (including but not limited to poorly controlled type Given the unique advantages of IVM as safer, simpler and 17 1 or type 2 diabetes mellitus; liver disease or dysfunc- cheaper, we need further evidence from well-designed randomised controlled trials (RCTs) on the live birth tion (based on serum liver enzyme test results); renal rate before we draw conclusions on the effectiveness and disease or abnormal serum renal function; anaemia; safety of IVM. Therefore, we plan an RCT to determine history of deep venous thrombosis, pulmonary whether IVM is non- inferior to standard IVF on live birth embolus or cerebrovascular accident; uncontrolled for women with PCOS. hypertension or known symptomatic heart disease; history of (or suspected) cervical carcinoma, endome- METHODS AND ANALYSIS trial carcinoma or breast carcinoma; and unexplained colporrhagia). Study design http://bmjopen.bmj.com/ This is a single- centre, non- inferiority RCT with a 1:1 ► Couples receiving donor sperm or donor oocytes. treatment ratio. The programme for enrolment, inter- ► Couples with indications or have the plan to receive ventions and evaluation during the study process is preimplantation genetic testing. shown in table 1. Figure 1 indicates a flowchart showing ► Women with a male partner diagnosed with the registration, allocation, treatment and follow-up of azoospermia. participants. ► Either a male partner or female partner with a known abnormal chromosome karyotype (chromosome poly- Study setting morphisms were not included). on September 30, 2021 by guest. Protected copyright. The trial is approved by the Ethics Committee of Peking ► Women who have undergone unilateral ovariectomy. University Third Hospital (2017sz-066). Women with Participants can leave the study at any time without any PCOS and infertility who scheduled for their first IVF consequences for their clinical treatments. attempt at Peking University Third Hospital (Beijing, China) will be recruited. Potentially eligible women will be given information about the study during their first Recruitment consultation. All the couples provided written informed Potentially eligible women will be informed
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