Kai-Lun Hu, Tingting Liao, Qiongfang Wu, Xiang Ma, Y Cao, Jichun Tan, Lifeng Tian, Yi-Xiang Wang, J. Yu, Yifeng Liu, Junzhao Zhao, Shuyun Zhao, Mengxi Li, Lingbo Cai, Fen-Ting Liu, Kwanghann Gan, Yan Xu, Y. Lynn Wang, Jie Cai, Beihong Zheng, Yanli Ma, Qianhong Ma, Jie Zheng, Xin Pu, Hongyan Zhang, Cuifang Hao, Qingzhen Xie, Cuilian Zhang, Lei Jiang, Su Zhang, Liping Yan, Qingxia Meng, Wentao Li, B.W. Mol, Rong Li, Rui Wang, Dan Zhang
Abstract Objective To evaluate whether vitamin D supplementation improves live birth rates in women with polycystic ovary syndrome undergoing in vitro fertilisation. Design Multicentre, double blind, placebo controlled, randomised clinical trial. Setting 24 fertility centres in China. Participants 876 participants with polycystic ovary syndrome undergoing in vitro fertilisation. Interventions Participants were randomised (1:1) to receive vitamin D 4000 IU/day or placebo before in vitro fertilisation for up to 90 days until the trigger day. Main outcomes measures The primary outcome was live birth after the first embryo transfer. Secondary outcomes included serum 25-hydroxyvitamin D (25-OHD) levels on trigger day, pregnancy outcomes, fertility outcomes, and adverse events including severe ovarian hyperstimulation syndrome. Results Of 876 participants randomised, 865 were included in the modified intention-to-treat analysis, with 435 in the vitamin D group and 430 in the placebo group. Baseline mean serum 25-OHD levels were 16.5±7.2 and 16.1±6.7 ng/mL in the vitamin D and placebo groups, respectively. On the day of triggering, the serum 25-OHD level was significantly higher in the vitamin D group than in the placebo group (32.3±11.2 v 18.2±7.6 ng/mL, adjusted mean difference 13.6, 95% confidence interval 10.9 to 16.3). 226 (52.0%) live births occurred in the vitamin D group and 216 (50.2%) in the placebo group (adjusted risk ratio 1.03, 95% confidence interval 0.91 to 1.18). Severe ovarian hyperstimulation syndrome occurred in three and six participants in the vitamin D and placebo groups, respectively (adjusted risk difference −0.7%, 95% confidence interval −2.0% to 0.6%). Conclusions Although vitamin D supplementation (4000 IU/day) for up to 90 days increases serum 25-OHD levels, this does not translate to improved live birth rates after the first transfer for patients with polycystic ovary syndrome. Trial registration ClinicalTrials.gov NCT04082650