Minimal Stimulation or Clomiphene Citrate as First Line Therapy in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate per cycle
研究概览
简要总结
The purpose of this study is to compare and determine the the efficacy of minimal stimulation and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic Ovary Syndrome(PCOS).
详细描述
All patients received 100 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. In group A (minimal stimulation), 2 vials of highly purified uFSH , 150 IU (Fostimon; IBSA, Lugano, Switzerland, 75 IU/vial) were given IM on cycle day 9. A total of 3 cycles was offered to each group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •No other infertility factors
- •No previous use of ovarian stimulation drugs
排除标准
- •Congenital adrenal hyperplasia
- •Cushing syndrome
- •Androgen secreting tumors
研究组 & 干预措施
minimal stimulation protocol
5 days of CC (100mg/day) from day 3 followed by 150 IU of highly purified uFSH on cycle day 9 for three treatment cycles
干预措施: clomiphene citrate +highly purified uFSH (Drug)
clomiphene citrate(CC)
5 days of CC (100mg/day) from cycle day 3 for three treatment cycles.
干预措施: clomiphene citrate (Drug)
结局指标
主要结局
clinical pregnancy rate per cycle
次要结局
- endometrial thickness at the time of hCG administration