Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- ovulation rate
研究概览
简要总结
Polycystic ovarian syndrome (PCOS) is a condition characterized by infertility, infrequent periods and amenorrhea or irregular bleeding plus anovulatory infertility. Clomid is the standard first drug of treatment for ovulation induction. Ovulation and conception will occur in approximately 75 and 30 percent of cases respectively. Cases not ovulating in response to doses of clomid up to 150 mg/day are known as clomid resistant PCOS.
详细描述
To test whether CC co- treatment with chronic low dose HP uFSH versus lirizole plus chronic low dose HP uFSH in CC resistant PCOS will yield comparable results in terms of, ovulation rate, lower follicle number, lower HP uFSH dose, better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates, lower cycle cancellation.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •CC resistant PCOS
- •Infertile
- •Age 18-38
排除标准
- •Hyperprolactinaemia
- •Cushing syndrome
- •Adult onset adrenal hyperplasia
- •Age > 38
- •Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis
研究组 & 干预措施
CC-plus uFSH
clomiphene citrate 50 mg tablets twice/day for cycle days 3-7 plus daily IM injection of 37.5 IU HP uFSH for days 3-12
干预措施: clomiphene citrate-uFSH arm (Drug)
Aromataze inhibitor plus uFSH
Aromataze inhibitor (litrezole )2.5 mg twice daily for cycle days 3-7 plus daily IM injection of uFSH 37.5 IU for cycle days 3-12
干预措施: Aromatase inhibitor (litrezole) plus uFSH arm (Drug)
结局指标
主要结局
ovulation rate
时间窗: 30 days
percentage of ovulatory cycles per started and per completed cycles
次要结局
- endometrial thickness(4 weeks)
- ongoing cycle pregnancy rate(16 weeks)
研究者
Mohamad Elsaid Ghanem
Dr
Mansoura Integrated Fertility Center