Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
The aim of this study is to test the hypothesis that addition of daily small dose of human menopausal gonadotropin (HMG) drug following oocytes retrieval could improve the fertility outcome in women undergoing in-vitro fertilization
详细描述
The study will be conducted in the IVF unit of Cairo University. Females undergoing ICSI cycles in the age between 20 and 40 years will be allocated to one of 2 groups. Long agonist protocol will be used. Allocation to either one of 2 groups will be done on the day of oocytes retrieval. The first group will take (in addition to the routine care) daily human menopausal gonadotropin drug injection for 2 weeks. The second group will receive the routine care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females undergoing Intra-Cytoplasmic Sperm Injection (ICSI) cycles
- •Age between 20 and 40 years
排除标准
- •Females who have high response (estradiol at time of ovulation trigger is > 5000 pg/ml or more than 15 oocytes are retrieved)
研究组 & 干预措施
Human menopausal gonadotropin (HMG)
This group will take daily subcutaneous 75 IU (international unit) of human menopausal gonadotropin (HMG) in addition to the usual luteal phase support from the day of ovum pickup and will be continued for 2 weeks
干预措施: human menopausal gonadotropin (Drug)
Routine care
This group will receive the routine care for luteal phase support
结局指标
主要结局
Live birth rate
时间窗: This outcome will be calculated 2 years after enrollment of the first patient in the study
The live birth rate will be calculated by a statistician for each group
次要结局
- Clinical pregnancy rate(This outcome will be calculated 2 years after enrollment of the first patient in the study)
- Implantation rate(This outcome will be calculated 2 years after enrollment of the first patient in the study)
- Miscarriage rate(This outcome will be calculated 2 years after enrollment of the first patient in the study)
研究者
Abdel-Maguid Ramzy
Professor
Cairo University