To compare the efficacy of two different regimens of GnRH antagonists in clomiphene-Gonadotropin induced controlled ovulation and IUI cycles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 2.Ovulation rates
研究概览
简要总结
This study is a randomized, open label, parallel group, three-arm controlled clinical trial in which the efficacy of two different regimens of GnRH antagonist i.e., Cetrorelix, in fixed and flexible regimens, was evaluated in clomiphene - gonadotropin induced controlled ovulation and intrauterine insemination cycles at All India Institute of Medical Sciences, New Delhi. The primary outcomes were premature luteinization rate and ovulation rates. The secondary outcomes were pregnancy rates, effect on endometrial thickness, effect on hormonal profiles, cycle cancellation rates and adverse effects like OHSS and multiple pregnancies.
Dosages of drug –
- Group I-Fixed day group (n =15 ) : Clomiphene 50 mg/d orally will be given on day 2 to 6 of menstrual cycle + GMH 75 IU IM will be given daily in the same dose from day 6 to day 8 and dose increased according to response after that + Cetrorelix 0.25mg s/c from day 8 + hCG 10,000 IU (more than 18 mm follicle) + IUI after 34-38 hours.
- Group 2-Flexible day group (n= 15 ) : Clomiphene 50mg/d orally will be given on day 2 to 6 of menstrual cycle + GMH 75 IU IM will be given daily in the same dose from day 6 to day 8 and dose increased according to response after that + Cetrorelix 0.25mg s/c @ follicle size ≥ 14 mm or if LH > 10 IU/L + hCG 10,000 IU (more than 18 mm follicle) + IUI after 34-38 hours.
- Group 3-control group (n=15 ) : Clomiphene 50mg/d orally will be given on day 2 to 6 of menstrual cycle + GMH 75 IU IM will be given daily in the same dose from day 6 to day 8 and dose increased according to response after that + hCG 10,000 (more than 18 mm follicle) + IUI after 34-38 hours.
Duration of treatment – Maximum of three cycles per patient.
Investigation specifically related to projects- serum estradiol , serum LH, Serum progestrone
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Unexplained infertility; 2)Mild male factor infertility; 3)Ovulation dysfunction infertility with previously failed induction with letrozole or clomiphene; 4)At least one patent fallopian tube; 5)BMI 18.5–29.9 kg/m2 6)Euthyroid state 7)No associated medical problems like diabetes mellitus or Hypertension or Drug allergies.
排除标准
- •Severe male factor infertility; 2)Stage III or IV endometriosis; 3)Tubal Factor Infertility; 4)baseline FSH >12 IU/L; 5)Less than four antral follicles per ovary.
结局指标
主要结局
2.Ovulation rates
时间窗: 1. If LH more than 10 mIU/ml and Progesterone more than 2ng/ml on day 10 and/or day 12 of menstrual cycle | 2. Documented by transvaginal ultrasound after 36 hours of ovulation trigger
1.Premature luteinization rate
时间窗: 1. If LH more than 10 mIU/ml and Progesterone more than 2ng/ml on day 10 and/or day 12 of menstrual cycle | 2. Documented by transvaginal ultrasound after 36 hours of ovulation trigger
次要结局
- 1.Pregnancy rate(2.Endometrial thickness)