Effectiveness and safety of in vitro maturation of oocytes versus in vitro fertilisation in women with high antral follicle count: study protocol for a randomised controlled trial

• Published in: BMJ open 2018-12, Vol.8 (12), p.e023413-e023413
• Main Authors: Vuong, Lan N, Ho, Vu N A, Ho, Tuong M, Dang, Vinh Q, Phung, Tuan H, Giang, Nhu H, Le, Anh H, Pham, Toan D, Wang, Rui, Norman, Rob J, Smitz, Johan, Gilchrist, Robert B, Mol, Ben W
• Format: Article
• Language: English
• Subjects: Adult; Clinical medicine; Clinical trials; Effectiveness; Embryo Transfer; Embryos; Evidence-based medicine; Female; Fertilization in Vitro; Humans; In vitro fertilization; In Vitro Oocyte Maturation Techniques; Infant, Newborn; Infertility; Menstruation; Ovarian Follicle; Ovarian Hyperstimulation Syndrome - prevention & control; Patient safety; Polycystic ovary syndrome; Polycystic Ovary Syndrome - complications; Pregnancy; Reproductive Medicine; Risk Factors; Treatment Outcome; Ultrasonic imaging; Vietnam; Womens health
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2018-023413

IntroductionIn vitro maturation (IVM) is a potential alternative to conventional in vitro fertilisation (IVF) to avoid ovarian hyperstimulation syndrome (OHSS). This is particularly relevant in women with a high antral follicle count (AFC) and/or polycystic ovary syndrome (PCOS), who are at increased risk for OHSS. However, no randomised controlled trials of IVM versus IVF in women with high AFC have reported both pregnancy and OHSS rates. The aim of this study is to compare the effectiveness and safety of one IVM cycle and one IVF with segmentation cycle within women with PCOS or high AFC-related subfertility.Methods and analysisThis randomised controlled trial will be conducted at a specialist IVF centre in Vietnam. Eligible subfertile women with PCOS and/or high AFC will be randomised to undergo either IVM or IVF. The primary outcome is live birth after the first embryo transfer of the started treatment cycle. Cycles in which no embryo is available for transfer will be considered as failures. The study has a non-inferiority design, with a maximal acceptable between-group difference of 5%. Rates of OHSS will also be reported.Ethics and disseminationEthical approval was obtained from the participating centre, and informed patient consent was obtained before study enrolment. Results of the study will be submitted for publication in a peer-reviewed journal.Trial registration number NCT03405701; Pre-results.