Effect of orlistat on live birth rate in overweight or obese women undergoing IVF-ET: A randomized clinical trial.

Context Obesity management prior to infertility treatment remains a challenge. To date, results from randomized clinical trials involving weight loss by lifestyle interventions have shown no evidence of improved live birth rate. Objective To determine whether pharmacologic weight-loss intervention before in vitro fertilization and embryo transfer (IVF-ET) can improve live birth rate among overweight or obese women. Design, setting, and participants We conducted a randomized, double-blinded, placebo-controlled trial across 19 reproductive medical centers in China, from July 2017 to January 2019. A total of 877 infertile women scheduled for IVF who had a body mass index of 25kg/m 2 or greater were randomly assigned. Interventions The participants were randomized to receive orlistat (n=439) or placebo (n=438) treatment for 4-12 weeks. Main outcomes and measures Live birth rate after fresh embryo transfer. Results The live birth rate was not significantly different between the two groups (112 of 439 [25.5%] with orlistat and 112 of 438 [25.6%] with placebo; P=.984). No significant differences existed between the groups as to the rates of conception, clinical pregnancy, and pregnancy loss. A statistically significant increase in singleton birthweight was observed after orlistat treatment (3487.50g versus 3285.17g in the placebo group; P=.039). The mean change in body weight during the intervention was -2.49kg in the orlistat group, as compared to -1.22kg in the placebo group, with a significant difference (P=.005). Conclusions Orlistat treatment, prior to IVF-ET, did not improve live birth rate among overweight or obese women, although it was beneficial for weight reduction.