Vitamin D Supplementation Prior to in Vitro Fertilization in Women With Polycystic Ovary Syndrome: a Protocol of a Multicenter Randomised Double-blind Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 876
- 试验地点
- 2
- 主要终点
- Number of Participants with live birth
研究概览
简要总结
This multicenter double-blinded placebo-controlled randomised trial aims to evaluate the effectiveness of vitamin D supplementation prior to IVF on the live birth rate in women with PCOS. Women with PCOS scheduled for IVF will be enrolled. Eligible participants will be randomised 1:1 to receive oral capsules of 4000IU vitamin D per day or placebo for around 12 weeks until the day of triggering.
详细描述
Polycystic ovary syndrome (PCOS) is one of the leading causes of female infertility, affecting around 5% of women with a child-bearing age in China. Vitamin D insufficiency is common in women with PCOS and is associated with lower live birth rates in these women. However, evidence regarding the effectiveness of vitamin D treatment in women with PCOS is inconclusive. This multicenter double-blinded placebo-controlled randomised trial aims to evaluate the effectiveness of vitamin D supplementation prior to IVF on the live birth rate in women with PCOS.
The investigators plan to enroll women with PCOS scheduled for IVF. Eligible participants will be randomised 1:1 to receive oral capsules of 4000IU vitamin D per day or placebo for around 12 weeks until the day of triggering. All IVF procedures will be carried out following a routine method in each center. Women will be followed up until six months after randomisation for those who fail to get pregnant after the completion of the first embryo transfer or delivery for those who get pregnant after the first embryo transfer. The primary outcome is live birth after the first embryo transfer. Primary analysis will be by intention-to-treat analysis. The investigators plan to recruit 860 women to demonstrate women treated with vitamin D have a higher live birth rate than those treated with placebo (48% versus 38%), accounting for 10% loss to follow-up with a significance level at 0.05 and a power of 80%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and most researchers will be unaware of the actual grouping. Only two researchers who are not involved in participant management or data analysis will be aware of the grouping.
Vitamin D and placebo pills with identical package, size, colour and appearance will be used in this trial. In general, there should be no need to unblind the allocation. If urgent unbinding to participants is necessary, the allocation will be disclosed to the treating physician.
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vitamin D
Participants in the intervention group will be treated with vitamin D 4000IU (800IU per pill, take five pills once each day) per day for around 12 weeks (till the triggering day).
干预措施: vitamin D (Drug)
Placebo
Participants in the control group will be treated with equal amount of placebo tablets per day for the same duration.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants with live birth
时间窗: 1 day after delivery
The primary outcome is live birth after the first embryo transfer. Live birth is defined as the delivery of at least one baby after 24 weeks of gestation that exhibits any sign of life.
次要结局
- Apgar score(1 minute or 5 minutes after delivery)
- Serum vitamin levels(One day before oocyte retrieval)
- Number of Participants with Clinical pregnancy(4 weeks after embryo transfer)
- Number of Participants with Ongoing pregnancy(at 12 weeks' gestation)
- Number of available embryos for transfer(5 days after oocyte retrieval)
- Number of Participants with Biochemical pregnancy(2 weeks after embryo transfer)
- Number of Participants with Pre-eclampsia(20 weeks of gestation till delivery)
- Number of Participants with Premature rupture of membrane(The day of delivery)
- birth weight(The day of delivery)
- Number of Participants with Cumulative live birth(6 months after randomization of the last participant)
- Number of Participants with Ectopic pregnancy(4 weeks after embryo transfer)
- Number of Participants with Gestational diabetes mellitus(Up to ten months once the participants get pregnancy)
- Number of Participants with Placenta previa(after 24 weeks of gestation)
- Number of Participants with Stillbirth(1 day after delivery)
- Number of Participants with Postpartum hemorrhage(1 day after delivery)
- Number of Participants with miscarriage(24 gestational weeks in maximum)
- Number of Participants with Ovarian hyperstimulation syndrome(From the day of oocyte retrieval to two weeks after embryo transfer)
- Number of Participants with Preterm delivery(1 day after delivery)
- Number of Participants with Gestational hypertension(20 weeks of gestation till delivery)
- Serum Vitamin D binding protein, glucose, insulin, Calcium ion concentration(The day of oocyte retrieval)
研究者
Dan Zhang
Vice president and Professor
Women's Hospital School Of Medicine Zhejiang University