Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Multiple pregnancy rates, OHSS rate
研究概览
简要总结
The purpose of this study is to compare the effectiveness of low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its endocrine response in patients who had previously failed to ovulate on clomiphen citrate alone. The investigators will also compare the effectiveness and endocrine response of this approach with the regimen of adding HMG to clomiphen citrate.
详细描述
Infertile women with PCOS, who have showed resistance to Clomiphen Citrate (150 mg- 5 days) in a previous IUI treatment cycle at Royan Institute (Infertility and Reproductive Medicine Research Centre) will enroll in this prospective randomized clinical trial study and will randomly be divided into three groups.
The study protocol will be assessed by an independent institutional review board and Royan ethics committee. All subjects will be given the written informed consent.
Control group (CC/hMG) will receive the 100 mg CC on days 3 to 7 of that cycle but will receive 150 mg human menopausal gonadotropin (HMG) during days of 7, 8, and 9. One of experimental Group (group B) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when the largest follicle is 12 mm or larger mean diameter. Other experimental group (Group C) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9(without attention to follicle size). In both experimental groups HCG administration will be continued until the largest follicle is 18-20 mm.
Ultrasound measurements of follicle number and growth, ovulation, gestational sac, and serum hormonal levels will be recorded and compared between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with PCOS diagnosed by the Rotterdam criteria
- •Previously documented dominant follicle or follicles (R12 mm mean diameter) on transvaginal Ultrasound follicular monitoring while receiving CC at the 150-mg dose in our clinic but have failed to ovulate;
- •Primary infertility
- •Documented normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy;
- •Male partner had to have a normal semen analysis by World Health Organization criteria.
排除标准
- •previous history of IVF or ICSI treatments.
- •History of hormonal treatment within recent three month (Except OCP, progesterone).
- •History of ovarian cutter or Ovarian drilling.
- •BMI higher than
- •The presence of ovarian cyst (more than 30 mm) during third cycle ultrasound.
研究组 & 干预措施
Low dose hCG group
干预措施: low dose human chorionic gonadotropin (Drug)
Clomiphen citrate plus HMG
干预措施: Clomiphen citrate plus HMG (Drug)
结局指标
主要结局
Multiple pregnancy rates, OHSS rate
时间窗: Within 20 months after recruiting
次要结局
- Pregnancy rate(Within 20 months after recruiting)
- The total dose of ovarian stimulation drugs(Within 20 months after recruiting)
- The number of embryos available for transfer(Within 20 months after recruiting)
- The embryo implantation rate and The live birth rate(Within 20 months after recruiting)