NCT01693289已完成1 期
Phase 1 Study of Efficacy of Combined Metformin-letrozole in Comparison With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- hormonal and metabolic changes
研究概览
简要总结
the study compare the hormonal-metabolic and reproductive outcome between combined metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic syndrome
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •polycystic ovary syndrome
- •infertility
- •clomiphene citrate resistance
排除标准
- •women with other causes of infertility as male factor or tubal factor, those with endocrine disorders as thyroid dysfunction and hyperprolactinemia women who received hormonal treatment or ovulation induction drugs 3 months prior to the study
- •pregnancy during follow up
研究组 & 干预措施
Metformin plus letrozole
Experimental
metformin :850mg tablets twice daily for 6 months letrozole :5mg tablets twice daily form day 3to7 of cycle
干预措施: metformin plus letrozole (Drug)
ovarian drilling
Experimental
bilateral diathermy ovarian drilling, four drills each ovary
干预措施: ovarian drilling (Procedure)
结局指标
主要结局
hormonal and metabolic changes
时间窗: 6 months
次要结局
- reproductive outcome(6months)
研究者
IBRAHIM ABD ELGAFOR
obstetrics and gynecology department
Zagazig University
研究点 (1)
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