A RANDOMIZED CONTROL TRIAL TO COMPARE EFFECTIVENESS OF CLOMIPHENE CITRATE VS TAMOXIFEN IN INDUCTION OF OVULATION IN ANOVULATORY INFERTILE WOMEN
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Incidence of ovulation
研究概览
简要总结
In this study participants are randomized into two groups Clomiphene Citrate CC or Tamoxifen TX
Cycle 1 Group CC receives Clomiphene 50 mg daily from Day2 to Day7
Follicle study is done from Day10 until ovulation
Non-responders move to Cycle 2 with increased doses
Group TX receives Tamoxifen 20 mg daily from Day2 to Day7 with the same monitoring process
Cycle 2 CC non-responders from Cycle 1 receive Clomiphene 100 mg
TX non-responders receive Tamoxifen 40 mg
Cycle 3 CC non-responders from Cycle 2 receive Clomiphene 150 mg
TX non-responders receive Tamoxifen 80 mg
For both groups hCG trigger is given when the dominant follicle reaches 18 to 20 mm and outcome of pregnancy is studied
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •35 years.
- •Body mass index (BMI):
- •Patients with normogonadotropichypogonadism (WHO type 2).
- •Normal semen analysis of the husband.
- •Normal serum Prolactin 6.Consenting to participate in the study.
排除标准
- •1.Thyroid dysfunction, active liver diseases.
- •Local diseases as endometriosis, ovarian tumors, hydro- or pyosalpinx etc.
- •Patients with previous history of Ovulation induction.
- •Patients with previous history of ovarian drilling.
- •5.Any Medical complications 6.Any Obstetrical complications
- •Any contraindication for Tab Clomiphene citrate or Tab Tamoxifen.
结局指标
主要结局
Incidence of ovulation
时间窗: Follicular scan from Day 11 of menstrual cycle till Day14
次要结局
- 1 Estimation of Endometrial thickness(2 Incidence of Pregnancy)
研究者
Dr P Santhosh
Karnataka Medical College and Research Institute Vidyanagar Hubballi