Efficacy of Combined Letrozole-metformin in Comparison With Letrozole Only in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The ovulation rate
研究概览
简要总结
Polycystic ovary syndrome accounts for the vast majority of anovulatory symptoms and hyperandrogenism in women. The diagnosis of Polycystic ovary syndrome has life-long implications, with increased risk for infertility, metabolic syndrome, and type 2 diabetes mellitus, and possibly for cardiovascular disease and endometrial carcinoma. Polycystic ovary syndrome is diagnosed in adolescents with otherwise unexplained, persistent hyperandrogenic anovulatory symptoms that are inappropriate for age and stage of adolescence. It should be considered in any adolescent girl with a chief complaint of hirsutism, treatment-resistant acne, menstrual irregularity, acanthosis nigricans, and/or obesity
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •polycystic ovaries patients who had failed to become pregnant after 3 courses of 150 mg of clomiphene citrate (considered as clomiphene resistant),whereas the value of the above mentioned investigation are normal.
排除标准
- •women with other causes of infertility as male factor,tubal factor,those with endocrine disorders as thyroid dysfunction and hyperprolactinemia.
- •women who received hormonal treatment or ovulation induction drugs in the last 3 months before the study.
- •women with history of liver,kidney or cardiovascular disease.
研究组 & 干预措施
letrozole plus metformin
5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding plus metformin will be started from the first day with a dose of 850 mg (1 tablet daily) and the dosage will be increased after 1 week up to 1,700 mg/day (2 tablets daily) and will be continued
干预措施: letrozole plus metformin (Drug)
letrozole
5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding
干预措施: letrozole (Drug)
结局指标
主要结局
The ovulation rate
时间窗: 14 days
次要结局
未报告次要终点