TO compare two drug combinations to improve pregnancy rate in infertile women with PCOS
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total number of women attaining clinical pregnancy in either group(confirmed by USG)
研究概览
简要总结
Insulin resistance is one of the main component of polycystic ovary syndrome. Metformin is an insulin sensitiser being used along with ovulation induction to improve pregnancy rate in infertile PCOS women. But main disadvantage of Metfomrin is gastro-intestinal side effects. Inositol have been recently studied in infertile PCOS women and have been seen to improve insulin resistance. Both Metformin and Myoinositol improve insulin resistance but through different mechanisms. The present study is being conducted to evaluate whether combination of Metformin and Myo-inositol will have better effect in terms of clinical pregnancy rate as compare to Myoinositol alone in infertile PCOS women.
In initial 3 months of study, only the drugs will be given and couples will be advised to try for natural conception. After 3 months, patients who will not conceive, will be given Letrozole with or without gonadotrophin for ovulation induction for 3 cycles.
Main primary outcome will be clinical pregnancy rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Infertile women with PCOS(according to Rotterdam criteria) 2.Women 20-38 years of age 3.BMI<30 kg/m2
- •Willing to participate in study and follow up.
- •5.Bilateral patent tubes on hysterosalpingography/laparoscopy.
排除标准
- •1.Patients already on other drugs for treatment of PCOS like OCPs. 2.Deranged kidney or liver function tests 3.Uncontrolled Thyroid disorders/impaired GTT/Diabetes mellitus.
- •4.Known hypersensitivity to Myoinositol or Metformin.
- •5.Moderate to severe male factor infertility.
- •6.Women with ny other endocrinological disorders.
结局指标
主要结局
Total number of women attaining clinical pregnancy in either group(confirmed by USG)
时间窗: 6 months
次要结局
- Ongoing pregnancy rate(POG12 wks)
- Total number of ectopic or multiple pregnancies.(6 months)
- Ovulation rate.
- Total number of OHSS cases.
- Total number of abortions occurring in present pregnancy.
- Improvement in clinical,metabolic and hormonal parameters in PCOS women.