Effects of Metformin on the Ovarian Response to Gonadotropins for in Vitro Fertilization Treatment in Patients With Polycystic Ovary Syndrome and Predictors of Poor Ovarian Response
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Rate of cancellation due to low ovarian response
研究概览
简要总结
Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking.
On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.
详细描述
Primary infertile patients with PCOS older than 35 years and/or with a basal follicle-stimulating hormone (FSH) level higher than 10 IU/L who were scheduled for IVF cycles were enrolled in the study protocol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Prognosis for poor response
- •Infertility
排除标准
- •Male factor infertility
- •Tubal infertility
研究组 & 干预措施
Metformin
Metformin pre-treatment and co-administration
干预措施: Metformin (Drug)
Placebo
Placebo pre-treatment and co-administration
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of cancellation due to low ovarian response
时间窗: one month
Number of cancelled cycles/total cycles
次要结局
- Stimulation length(one month)
- Gonadotropins dose(one month)
- Ovulation rate(one month)
- pregnancy rate(one month)
- Live-birth rate(nine months)
- Adverse effects(one month)