In vitro maturation (IVM) versus in vitro fertilization (IVF) in women with high antral follicle count (AFC): a randomized controlled trial (NCT03405701).

Objective: IVM has been proposed as an alternative to IVF for women at increased risk of ovarian hyperstimulation syndrome (OHSS) due to a high antral follicle count (AFC) and/or polycystic ovary syndrome (PCOS). Here, we compare the effectiveness and safety of one IVM and one IVF cycle in women with infertility and high AFC. Design(s): A single-center noninferiority randomized controlled trial (NCT03405701) in Vietnam. Material(s) and Method(s): Women scheduled for assisted reproductive technology (ART) with an AFC>=24 were randomized (1:1 ratio) to IVM or IVF. In the IVM group, oocyte pick-up was performed 42 hours after the last injection of highly purified human menopausal gonadotropin (hp-hMG) 150 IU/day; all oocytes were cultured in capacitation pre-maturation medium for 24 h and then transferred to maturation culture for 30 h. Women allocated to IVF underwent ovarian stimulation using a hp-hMG/gonadotropin releasing hormone (GnRH) antagonist protocol and oocytes were retrieved 36 h after GnRH agonist trigger. In both groups, mature oocytes were fertilized using intracytoplasmic sperm injection, and all embryos were frozen on day 3; <=2 embryos were transferred in a subsequent frozen cycle. The primary outcome was live birth after first embryo transfer of the started treatment cycle. The planned sample size was 546, assuming an expected live birth rate of 45% in the IVF group, a noninferiority margin of -10%, 90% power and 15% loss to follow-up. While follow-up for live birth is ongoing, we report ongoing pregnancy in this abstract. Result(s): Between January 2018 and December 2018, we randomized 546 women (273 in each group). Baseline characteristics were comparable (mean age 30 years, BMI 22 kg/m2). The ongoing pregnancy rates after the first embryo transfer were 38% and 46%, respectively (difference -8.1% [-16.7%, 0.6%]). Other fertility outcomes after first embryo transfer were also not statistically significant between the groups (Table). All laboratory o