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DOI http://dx.doi.org/10.1136/bmjopen-2018-023413

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 Vuong1,2, Vu N A Ho2, Tuong M Ho2, Vinh Q Dang2, Tuan H Phung2, Nhu H Giang2, Anh H Le2, Toan D Pham2, Rui Wang3, Rob J Norman3,4, Johan Smitz5, Robert B Gilchrist6, Ben W Mol7

  1. Department of Obstetrics and GynaecologyUniversity of Medicine and Pharmacy at Ho Chi Minh CityHo Chi Minh CityVietnamIVFMDMy Duc HospitalHo Chi Minh CityVietnam
  2. IVFMDMy Duc HospitalHo Chi Minh City, Vietnam
  3. Robinson Research Institute and Adelaide Medical SchoolThe University of AdelaideAdelaideSouth Australia, Australia
  4. Fertility SAAdelaideSouth Australia, Australia
  5. Follicle Biology LaboratoryFree University of Brussels (VUB)Brussels, Belgium
  6. School of Women’s and Children’s HealthUniversity of New South WalesSydneyNew South Wales, Australia
  7. Department of Obstetrics and GynaecologySchool of Medicine, Monash UniversityMelbourneVictoria, Australia
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

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