Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients : A Prospective Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- ivf-et outcomes
研究概览
简要总结
The purpose of this study is to determine whether simvastatin is effective in the improvement of IVF-ICSI outcome in Pcos patients.
详细描述
simvastatin reduces cardiovascular risks by improving hypercholesterolemia, reducing vascular smooth muscle proliferation, ameliorating inflammation, limiting theca-interstitial proliferation & decreasing steroidogenesis (production of progesterone & testosterone).Polycystic ovary syndrome (pcos) is associated with increased cardiovascular risks and is characterized by ovarian theca-interstitial hyperplasia& hyperandrogenism .This study will test the hypothesis that simvastatin improves biochemical parameters& IVF-ICSI outcome in Pcos patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pcos patients
- •Age <40 years
- •FSH<10 IU/L
排除标准
- •Endometriosis grade 3 &4
- •History of tubal surgery
- •Hydrosalpinx
- •History of mellitis diabetes
研究组 & 干预措施
B
干预措施: SIMVASTATIN (Drug)
A
干预措施: SIMVASTATIN (Drug)
结局指标
主要结局
ivf-et outcomes
时间窗: 14-20 days
次要结局
- Biochemical parameters baseline and 8weeks Biochemical parameters(baseline and 8weeks)