An interventional trial to see the effect of combination of clomiphene citrate and letrozole in infertile women with polycystic ovarian syndrome not responding to either clomiphene citrate or letrozole used as single drug.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ovulation will be assessed as primary outcome
研究概览
简要总结
Patients will be approached for enrollment after checking inclusion and exclusion criteria.
Recruitment will be done after taking consent.
Trial drugs given in combination from day 2-5 of cycle for 5 days.
serial transvaginal ultrasound will be done from day 11 to 18 to see follicle development, endometrial thickness and number of follicles.
day 21 serum progesterone or TVS will be done to confirm ovulation.
patients advised to follow up on day 2 or 3 of next cycle or if overdue after 1 week
pregnancy will be checked by urinary hCG
TVS will be dne to see number of sacs and site of pregnancy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients with PCOS not responding to either clomiphene citrate 100 mg or letrzole 2.5 mg.
排除标准
- •Hypothyroidism Hyperthyroidism Hyperprolactinemia Male factor infertility Tubal factor infertility Uncontrolled Diabetes, History of DVT, liver disease.
结局指标
主要结局
Ovulation will be assessed as primary outcome
时间窗: Will be assessed on day 21 or after 7 days of dominant follicle formation
次要结局
- Endometrial thickness(Number of follicles)
研究者
Shavina Bansal
Post Grauate Institute of medical educationand research