Vitamin D supplementation before in vitro fertilisation in women with polycystic ovary syndrome: multicentre, double blind, placebo controlled, randomised clinical trial.

Methods

Multicentre, double blind, placebo controlled, randomised clinical trial.

多中心、双盲、安慰剂对照、随机临床试验。

24 fertility centres in China.

中国24个生殖中心。

876 participants with polycystic ovary syndrome undergoing in vitro fertilisation.

876名接受体外受精的多囊卵巢综合征患者。

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.

参与者被随机分配（1:1），在体外受精前每天接受4000 IU的维生素D或安慰剂，最多持续90天，直到触发日。

main_outcomes_measures

The primary outcome was live birth after the first embryo transfer.

主要结果是在第一次胚胎移植后的活产。

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.

次要结果包括触发日的血清25-羟维生素D（25-OHD）水平、妊娠结果、生育结果以及包括严重卵巢过度刺激综合征在内的不良事件。

Results

Of 876 participants randomised, 865 were included in the modified intention-to-treatanalysis, with 435 in the vitamin D group and 430 in the placebo group.

在随机分配的876名参与者中，有865名被纳入修改后的意向治疗分析，其中维生素D组435人，安慰剂组430人。

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.

基线时，维生素D组和安慰剂组的血清25-OHD平均水平分别为16.5±7.2和16.1±6.7 ng/mL。

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 interval10.9 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 interval0.91 to 1.18).

触发当天，维生素D组的血清25-OHD水平显著高于安慰剂组（32.3±11.2 vs 18.2±7.6 ng/mL，调整后平均差异13.6，95%置信区间10.9至16.3）。维生素D组有226例（52.0%）活产，而安慰剂组有216例（50.2%）（调整后风险比1.03，95%置信区间0.91至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%).

在维生素D组和安慰剂组中，分别有三名和六名参与者出现了严重的卵巢过度刺激综合征（调整后的风险差异为-0.7%，95%置信区间为-2.0%至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.

尽管每天补充4000国际单位的维生素D长达90天可以提高血清25-OHD水平，但这并没有转化为多囊卵巢综合征患者首次移植后活产率的提高。

trial_registration

ClinicalTrials.gov NCT04082650.

ClinicalTrials.gov NCT04082650。