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STUDY QUESTION: Is one cycle of IVM non-inferior to one cycle of conventional in IVF with respect to live birth rates in women with high antral follicle counts (AFCs)? SUMMARY ANSWER: We could not demonstrate non-inferiority of IVM compared with IVF. WHAT IS KNOWN ALREADY: IVF with ovarian hyperstimulation has limitations in some subgroups of women at high risk of ovarian stimulation, such as those with polycystic ovary syndrome. IVM is an alternative ART for these women. IVM may be a feasible alternative to IVF in women with a high AFC, but there is a lack of data from randomized clinical trials comparing IVM with IVF in women at high risk of ovarian hyperstimulation syndrome. STUDY DESIGN, SIZE, DURATION: This single-center, randomized, controlled non-inferiority trial was conducted at an academic infertility center in Vietnam from January 2018 to April 2019. PARTICIPANTS/MATERIALS, SETTING, METHODS: In total, 546 women with an indication for ART and a high AFC (>=24 follicles in both ovaries) were randomized to the IVM (n = 273) group or the IVF (n = 273) group; each underwent one cycle of IVM with a prematuration step versus one cycle of IVF using a standard gonadotropin-releasing hormone antagonist protocol with gonadotropin-releasing hormone agonist triggering. The primary endpoint was live birth rate after the first embryo transfer. The non-inferiority margin for IVM versus IVF was-10%. MAIN RESULTS AND THE ROLE OF CHANCE: Live birth after the first embryo transfer occurred in 96 women (35.2%) in the IVM group and 118 women (43.2%) in the IVF group (absolute risk difference-8.1%; 95% confidence interval (CI)-16.6%, 0.5%). Cumulative ongoing pregnancy rates at 12 months after randomization were 44.0% in the IVM group and 62.6% in the IVF group (absolute risk difference-18.7%; 95% CI-27.3%,-10.1%). Ovarian hyperstimulation syndrome did not occur in the IVM group, versus two cases in the IVF group. There were no statistically significant differences between the

Background: The use of intracytoplasmic sperm injection has increased substantially worldwide, primarily in couples with non-male factor infertility. However, there is a paucity of evidence from randomised trials supporting this approach compared with conventional in-vitro fertilisation (IVF). We aimed to investigate whether intracytoplasmic sperm injection would result in a higher livebirth rate compared with conventional IVF. Method(s): This open-label, multicentre, randomised trial was done at two IVF centres in Ho Chi Minh City, Vietnam (IVFMD, My Duc Hospital and IVFAS, An Sinh Hospital). Eligible couples were aged at least 18 years and the male partner's sperm count and motility (progressive motility) were normal based on WHO 2010 criteria. Couples had to have undergone two or fewer previous conventional IVF or intracytoplasmic sperm injection attempts, have used an antagonist protocol for ovarian stimulation, and agree to have two or fewer embryos transferred. Couples were randomly assigned (1:1) to undergo either intracytoplasmic sperm injection or conventional IVF, using block randomisation with variable block size of 2, 4, or 8 and a telephone-based central randomisation method. The computer-generated randomisation list was prepared by an independent statistician who had no other involvement in the study. Embryologists and couples were not masked to study groups because of the type of interventions and differences in hospital fees, but clinicians performing embryo transfer were unaware of study group allocation. The primary outcome was livebirth after the first embryo transfer from the initiated cycle. Analyses were done on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03428919. Finding(s): Between March 16, 2018, and Aug 12, 2019, we randomly assigned 1064 couples to intracytoplasmic sperm injection (n=532) or conventional IVF (n=532). Livebirth after the first embryo transfer from the initiated cycle occurred in 184 (35

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

STUDY QUESTION: Is a freeze-only strategy more cost-effective from a patient perspective than fresh embryo transfer (ET) after one completed In Vitro Fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI) cycle in women without polycystic ovary syndrome (PCOS)? SUMMARY ANSWER: There is a low probability of the freeze-only strategy being cost-effective over the fresh ET strategy for non-PCOS women undergoing IVF/ICSI. WHAT IS KNOWN ALREADY: Conventionally, IVF embryos are transferred in the same cycle in which oocytes are collected, while any remaining embryos are frozen and stored. We recently evaluated the effectiveness of a freeze-only strategy compared with a fresh ET strategy in a randomized controlled trial (RCT). There was no difference in live birth rate between the two strategies. STUDY DESIGN, SIZE, DURATION: A cost-effectiveness analysis (CEA) was performed alongside the RCT to compare a freeze-only strategy with a fresh ET strategy in non-PCOS women undergoing IVF/ICSI. The effectiveness measure for the CEA was the live birth rate. Data on the IVF procedure, pregnancy outcomes and complications were collected from chart review; additional information was obtained using patient questionnaires, by telephone. PARTICIPANTS/MATERIALS, SETTING, METHODS: For all patients, we measured the direct medical costs relating to treatment (cryopreservation, pregnancy follow-up, delivery), direct non-medical costs (travel, accommodation) and indirect costs (income lost). The direct cost data were calculated from resources obtained from patient records and prices were applied based on a micro-costing approach. Indirect costs were calculated based on responses to the questionnaire. Patients were followed until all embryos obtained from a single controlled ovarian hyperstimulation cycle were used or a live birth was achieved. The incremental cost-effectiveness ratio (ICER) was based on the incremental cost per couple and the incremental live birth rate of the freeze-only