“Effect of combination of letrozole with clomiphene citrate versus letrozole alone on pregnancy rate in subfertile women with polycystic ovarian syndrome: A randomized control trialâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Conception: a positive serum or urinary test of hCG
研究概览
简要总结
In reproductive age group, polycystic ovarian syndrome (PCOS) is most common cause of anovlatory subfertility. Therefore the treatment of subfertility in these women is targeted on ovulation induction.Till date various regimen have been tried to improve ovulation rate, pregnancy rate and live birth. Clomiphene citrate is commonly used for induction in women with PCOS. Letrozole is another drug commonly used as ovulation induction agent in women with poly cystic ovarian syndrome.Because letrozole and clomiphene have different mechanism of action we hypothesized that the combination of these two drugsmay result in an increased pregnancy rate over letrozole alone in women with PCOS.
Objectives: Estimation of pregnancy rate between two groups and estimation of ovulation rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women from age of 18-40 years diagnosed with subfertility with PCOS and no other detectable cause of infertility.
- •Proven patency of at least one fallopian tube.
- •Sperm count of 15 million/ml and more than 40% motility will be included.
排除标准
- •Women having other cause of subfertility.
- •Recent use of hormonal contraception.
- •Hyperprolactinemia, untreated thyroid disease, uncontrolled diabetes.
- •Drug allergy or contraindication to letrozole or clomiphene citrate.
结局指标
主要结局
Conception: a positive serum or urinary test of hCG
时间窗: 1-3 months
次要结局
- Number and size of developing follicle on day 12-14, endometrial thickness on day 12-14, clinical pregnancy: an intrauterine gestational sac, complication related to study medication(1-3 months)