Dose Vitamin-D Supplementation Affect Reproductive Outcomes in Patients With Polycystic Ovary Syndrome?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not
详细描述
This study is double blinded randomized controlled study conducted at Tanta University hospitals in the period from April 2019 to March 2022. Patients and methods: One hundred twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin D supplementation and control group without Vitamin D supplementation.
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
- Double (Participant, Care Provider)
盲法说明
Both patients and gynecologists were binded
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
- •Infertile
- •Vitamin D deficient
排除标准
- •Age less than 20 and more than 35
- •Non PCOS patients
- •Obese patients
- •Previous ovarian surgery
- •Previous oophrectomy of one ovary
研究组 & 干预措施
Placebo group
These group will receive placebo for the same periods of study group
干预措施: Placebo Oral Tablet (Drug)
Vitamin D group
These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study
干预措施: Vitamin D (Drug)
结局指标
主要结局
Pregnancy rate
时间窗: 3 months
Number of patients who get pregnant
Ovulation rate
时间窗: 3 months
Number of mature follicles obtained
次要结局
未报告次要终点
研究者
Ayman S Dawood, MD
Lecturer
Tanta University