Vitamin D Supplementation in Vitamin Deficient Women Undergoing ICSI Cycles: Does it Affect the Fertility Outcome?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of this study is to evaluate the effect of treatment of vitamin D deficiency (through vitamin D supplementation for 8 weeks before the start of In-vitro fertilization (IVF) on the success of IVF cycles.
详细描述
The study participants are vitamin D deficient females undergoing (intra-cytoplasmic sperm injection (ICSI) trial in the age of 20 to 35 years. Serum vitamin D will be assessed. Accordingly, if they are deficient in vitamin D, they will be eligible for the study.400 vitamin D deficient women will be randomly allocated to either one of two groups. The first group will receive vitamin D supplementation in addition to the routine care. The other group will receive the routine care only. The study will be conducted in the IVF unit of department of Obstetrics and Gynecology, Cairo University.
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
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Vitamin D deficient females undergoing first ICSI trial
- •Age from 20 to 35 years
排除标准
- •Women undergoing ICSI trials who are vitamin D sufficient
研究组 & 干预措施
Vitamin D supplement
This group will receive weekly oral 50000 international units of vitamin D supplement for 8 weeks before the start of ICSI cycle. In addition, the routine care will be given.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: It will be calculated 1 year after enrollment of the first patient in the study
This outcome will be calculated by a statistician
次要结局
未报告次要终点
研究者
Eman Omran
Principal investigator
Cairo University