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

Lan N Vuong, Vu N A Ho, Tuong M Ho, Vinh Q Dang, Tuan H Phung, Nhu H Giang, Anh H Le, Toan D Pham, Rui Wang, Rob J Norman, Johan Smitz, Robert B Gilchrist, Ben W Mol, Lan N Vuong, Vu N A Ho, Tuong M Ho, Vinh Q Dang, Tuan H Phung, Nhu H Giang, Anh H Le, Toan D Pham, Rui Wang, Rob J Norman, Johan Smitz, Robert B Gilchrist, Ben W Mol

Abstract

Introduction: In 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 analysis: This 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 dissemination: Ethical 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.

Keywords: In-vitro fertilisation; high antral follicle count; in-vitro maturation of coocytes; live birth; ongoing pregnancy; polycystic ovary syndrome.

Conflict of interest statement

Competing interests: LNV has received speaker and conference fees from Merck, grant, speaker and conference fees from Merck Sharpe and Dohme, and speaker, conference and scientific board fees from Ferring. TMH has received speaker fees from Merck, Merck Sharp and Dohme, and Ferring. RJN has received grants and conference fees from Merck, grants and speaker fees from Merck Sharp and Dohme, and conference and scientific board fees for Ferring. BWM has acted as a paid consultant to Merck, ObsEva and Guerbet, and is the recipient of grant money from the NHMRC Practitioner Fellowship. RBG reports grants from National Health and Medical Research Council of Australia. JS reports grants from Fund for research Flanders, and has a patent WO 201609497 A1 pending. TDP, VQD, VNAH, NHG, AHL, THP and RW have no conflicts of interest to declare.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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