Vitamin D supplementation prior to in vitro fertilisation in women with polycystic ovary syndrome: a protocol of a multicentre randomised, double-blind, placebo-controlled clinical trial.
Vitamin D supplementation prior to in vitro fertilisation in women with polycystic ovary syndrome: a protocol of a multicentre randomised, double-blind, placebo-controlled clinical trial.
复制标题
多囊卵巢综合征女性体外受精前补充维生素 D：多中心随机、双盲、安慰剂对照临床试验方案
DOI：
10.1136/bmjopen-2020-041409
复制
发表时间：
2020-12-08
期刊：
影响因子：
2.9
通讯作者：
Zhang D
中科院分区：
文献类型：
--
作者：
Hu KL;Gan K;Wang R;Li W;Wu Q;Zheng B;Zou L;Zhang S;Liu Y;Wu Y;Chen R;Cao W;Yang S;Liu FT;Tian L;Zeng H;Xu H;Qiu S;Yang L;Chen X;Pan X;Wu X;Mol BW;Li R;Zhang D
介绍多囊卵巢综合征（PCOS）是女性不孕症的主要原因之一，在中国约有5%的育龄妇女受到影响。维生素D不足在PCOS女性中很常见，与活产率较低有关。然而，关于维生素D补充剂对PCOS妇女的有效性的证据尚不确定。这项多中心随机、双盲、安慰剂对照试验旨在评估体外受精（IVF）前补充维生素D对PCOS妇女活产率的有效性。方法和分析我们计划招募计划进行IVF的PCOS妇女。知情同意后，合格的参与者将以1：1的比例随机接受每天4000 IU维生素D或安慰剂的口服胶囊，持续约12周，直到触发当天。所有IVF程序将在每个中心常规进行。主要结局是第一次胚胎移植后的活产。主要分析将通过意向治疗分析进行。为了证明或反驳维生素D治疗的活产率比安慰剂治疗高10%，我们需要招募860名妇女（48% vs 38%的差异，预计失访和不依从率为10%，显著性水平为0.05，把握度为80%）。伦理与传播本研究已于2020年3月2日获得浙江大学附属妇产科医院伦理委员会批准（参考编号：IRB-20200035-R）。所有受试者将在随机化前提供书面知情同意书。研究结果将提交给科学会议和同行评审期刊。试验注册号NCT 04082650。
Introduction Polycystic ovary syndrome (PCOS) is one of the leading causes of female infertility, affecting around 5% of women of childbearing age in China. Vitamin D insufficiency is common in women with PCOS and is associated with lower live birth rates. However, evidence regarding the effectiveness of vitamin D supplementation in women with PCOS is inconclusive. This multicentre randomised, double-blinded, placebo-controlled trial aims to evaluate the effectiveness of vitamin D supplementation prior to in vitro fertilisation (IVF) on the live birth rate in women with PCOS. Methods and analysis We plan to enrol women with PCOS scheduled for IVF. After informed consent, eligible participants will be randomised in a 1:1 ratio to receive oral capsules of 4000 IU vitamin D per day or placebo for around 12 weeks until the day of triggering. All IVF procedures will be carried out routinely in each centre. The primary outcome is live birth after the first embryo transfer. The primary analysis will be by intention-to-treat analysis. To demonstrate or refute that treatment with vitamin D results in a 10% higher live birth rate than treatment with placebo, we need to recruit 860 women (48% vs 38% difference, anticipating 10% loss to follow-up and non-compliance, significance level 0.05 and power 80%). Ethics and dissemination This study has been approved by the Ethics Committee in Women’s Hospital of Zhejiang University on 2 March 2020 (reference number: IRB-20200035-R). All participants will provide written informed consent before randomisation. The results of the study will be submitted to scientific conferences and a peer-reviewed journal. Trial registration number NCT04082650.
登录
查看更多内容
影响因子：
9.8
作者：
Li, Hang Wun Raymond;Brereton, Rebecca E.;Ho, Clement K. M.
通讯作者：
Ho, Clement K. M.
影响因子：
5.9
作者：
Jamilian M;Foroozanfard F;Rahmani E;Talebi M;Bahmani F;Asemi Z
通讯作者：
Asemi Z
影响因子：
3.7
作者：
Lu HK;Zhang Z;Ke YH;He JW;Fu WZ;Zhang CQ;Zhang ZL
通讯作者：
Zhang ZL
影响因子：
6.1
作者：
HERMAN, A;RONEL, R;CASPI, E
通讯作者：
CASPI, E
影响因子：
2.2
作者：
Foroozanfard, Fatemeh;Talebi, Maesoomeh;Asemi, Zatollah
通讯作者：
Asemi, Zatollah