Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of mature oocytes
研究概览
简要总结
The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.
详细描述
Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.
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
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 14 follicles >11mm on the day of triggering final oocyte maturation
- •Pretreated with GnRH antagonist protocol
排除标准
- •Poor responders
- •Women with 25 or more follicles on the day of trigger
研究组 & 干预措施
rHCG 250 ug
Injection of 250 ug Ovitrelle to trigger final oocyte maturation
干预措施: rHCG 250ug (Drug)
uHCG 5000 IU
Injection of 5000 IU Pregnyl to trigger final oocyte maturation
干预措施: uHCG 5000 IU (Drug)
uHCG 7500 IU
Injection of 7500 IU Pregnyl to trigger final oocyte maturation
干预措施: uHCG 7500 IU (Drug)
结局指标
主要结局
Percentage of mature oocytes
时间窗: Day of oocyte retrieval (Day 0)
Percentage MII/COCs
次要结局
- Positive test per embryo transfer(15 days post oocyte retrieval)
- Clinical pregnancy per embryo transfer(7 weeks of gestation)
- Ongoing pregnancy per embryo transfer(12 weeks of gestation)
- Level of serum hCG on day of oocyte retrieval(Day of oocyte retrieval)
- Number of oocytes (COC) retrieved(Day of oocyte retrieval)
- Number of mature oocytes (MII)(Day of oocyte retrieval)
- Oocyte retrieval rate(Day of oocyte retrieval (Day 0))
- Incidence of severe early OHSS(up to Day 5 post oocyte retrieval)