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

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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.

Original languageEnglish
Article numbere023413
Number of pages6
JournalBMJ Open
Volume8
Issue number12
DOIs
Publication statusPublished - 1 Dec 2018

Cite this

Vuong, L. N., Ho, V. N. A., Ho, T. M., Dang, V. Q., Phung, T. H., Giang, N. H., Le, A. H., Pham, T. D., Wang, R., Norman, R. J., Smitz, J., Gilchrist, R. B., & Mol, B. W. (2018). 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. BMJ Open, 8(12), [e023413]. https://doi.org/10.1136/bmjopen-2018-023413