Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).
研究概览
简要总结
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.
详细描述
Withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation. In the letrozole group, 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days, whereas all patients in the combined metformin-CC group) received metformin HCl [Cidophage®; Chemical Industries Development(CID), Cairo, Egypt], 500 mg three times daily for 6-8 weeks. Then after the end of this period, they received 150 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of menstruation. Patients continued treatment for three successive cycles using the same protocol. Metformin was stopped only when pregnancy was documented.
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
- 20 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •CC resistant PCOS
排除标准
- •Congenital adrenal hyperplasia
- •Cushing syndrome
- •Androgen secreting tumors
研究组 & 干预措施
Letrozole
干预措施: Letrozole tablets (Femara; Novartis Pharma, Switzerland) (Drug)
Metformin-CC
干预措施: metformin HCl (Cidophage®; CID,Cairo, Egypt) (Drug)
Metformin-CC
干预措施: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) (Drug)
结局指标
主要结局
Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).
次要结局
- The occurrence of pregnancy and miscarriage.