A Randomized Double-blind Placebo-controlled Trial to Investigate the Effect of Vitamin D Supplementation in Live Birth Rate of in Vitro Fertilization Outcome
试验速览
- 阶段
- 4 期
- 入组人数
- 1,150
- 试验地点
- 2
- 主要终点
- Live birth rate
研究概览
简要总结
This is a randomized-controlled trial evaluating the effect of the use of vitamin D supplementation on the live birth rate in women undergoing in vitro fertilization (IVF). The hypothesis is that administration of vitamin D can increase the live birth rate for women undergoing IVF.
详细描述
Patients undergoing IVF treatment cycle at Queen Mary Hospital and Kwong Wah Hospital will be invited to participate in this study. Participating subjects will be randomized into either (i) vitamin D or (ii) placebo group in a 1:1 allocation ratio by computer-generated random numbers one month before IVF.
Subjects allocated to the vitamin D group will take vitamin D 50,000IU per week from recruitment for 4 weeks, followed by 50,000IU once every 2 weeks throughout the IVF cycle until fetal viability is confirmed at 6 weeks (if pregnant), after which they will be switched to Materna. If not pregnant, they will continue Vitamin D 50,000IU once every 2 weeks until 6 months from randomization, during which they can undergo frozen-thawed embryo transfer.
Subjects allocated to the placebo group will take placebo tablets which will be identical to the active drug. If pregnant and fetal viability is confirmed at 6 weeks, they will be switched to Materna. If not pregnant, they will continue the placebo tablets until 6 months from randomization, during which they can undergo frozen-thawed embryo transfer.
The clinician and patients will both be blinded to the randomization throughout the course of treatment. The live birth rate of the two groups will be compared.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women undergoing IVF
- •Aged between 18 and 43 years old, inclusive, at the time of signing informed consent
- •Having given voluntary written informed consent
排除标准
- •Already taking vitamin D
- •Undergoing preimplantation genetic testing
- •Use of donor oocytes or donor embryos
- •Presence of hydrosalpinx not corrected surgically
- •Active tuberculosis/ receiving therapy for tuberculosis
- •History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/or hypercalcemia, including history of renal/ureteral stones, parathyroid disease, renal or liver failure, current use of anticonvulsants, current use of steroid
- •Allergy to vitamin D
- •Abnormal serum calcium values
研究组 & 干预措施
Placebo
Placebo tablets identical to the active drug for 4 weeks from recruitment, followed by placebo tablets once every 2 weeks throughout the IVF cycle. Subjects to stop own supplements and folic acid will be provided. If pregnant and fetal viability confirmed at 6 weeks gestation, switch to Materna until delivery.
If not pregnant, to continue placebo tablets once every 2 weeks until 6 months from recruitment.
The rest of the IVF, embryo transfer procedure and antenatal care will be the same as usual practice.
干预措施: Placebo (Dietary Supplement)
Vitamin D
Vitamin D 50,000IU per week for 4 weeks from recruitment, followed by 50,000IU per week every 2 weeks throughout the IVF cycle. Subjects to stop own supplements and folic acid will be provided. If pregnant and fetal viability confirmed at 6 weeks gestation, switch to Materna until delivery.
If not pregnant, to continue vitamin D 50,000IU once every 2 weeks until 6 months from recruitment.
The rest of the IVF, embryo transfer procedure and antenatal care will be the same as usual practice.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Live birth rate
时间窗: 10 months
per embryo transfer procedure
次要结局
- Clinical pregnancy rate(10 weeks)
- Cumulative pregnancy rate within 6 months of randomization(6 months)
- Adverse events(6 months)
- Serum and follicular vitamin D levels(6 weeks)
- Ongoing pregnancy rate(12 weeks)
- Pregnancy rate(8 weeks)