A Phase IV Study on the Effect of Luteal Supplementation With Rec-LH on the Pregnancy Rate After Ovulation Triggering With GnRH-agonist Instead of HCG in IVF Protocol;Proof of Concept
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- pregnancy occurrence, pregnancy loss
研究概览
简要总结
Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of OHSS.
详细描述
Whether pregnancy outcome after GnRH-agonist triggering could be improved by adding luteal recLH support plus progesterone, compared to that observed after ovulation triggering with HCG in GnRH antagonist stimulated cycles.
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •< 36years,
- •single blastocystET,
- •FSH < 12
排除标准
- •endometriosis,
- •frozen sperm
研究组 & 干预措施
HCG for ovulation triggering and luteal progesterone
conventional triggering with HCG and conventional luteal support with progesterone
干预措施: progesterone 600mg (Drug)
Agonist triggering and rec-LH luteal support plus progesterone
new method of triggering with GnRH-agonist and proof of concept intervention with novel way of luteal support with rec-LH plus the usual co-treatment with progesterone
干预措施: 300IU rec-LH (Drug)
结局指标
主要结局
pregnancy occurrence, pregnancy loss
时间窗: 14 days after OPU
次要结局
- hormone levels, OHSS, endometrium(14 days after oocyte pick up)