Dual Trigger With Gonadotropin-releasing Hormone Agonist (GnRHa) and Human Chorionic Gonadotropin (hCG) to Optimize ICSI Reproductive Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- embryo implantation rate
研究概览
简要总结
The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole use results in reduced embryo implantation due to luteal phase insufficiency. The combination of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to overcome the luteal phase insufficiency effecting endometrial receptivity.
In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in normoresponders will increase oocyte maturity, embryo quality and embryo implantation and reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose) alone trigger.
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
- Double (Participant, Investigator)
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
- •Age; < 40 years
- •Cycle number; cycles 1 or 2
- •Antral follicle count; >10 and <25
- •BMI; >18 and <30
- •Normogonadotrophic cycle length; 24 to 25 days
- •Male; ejaculated semen only
排除标准
- •Presence of endocrine disorders; (diabetes mellitus, hyperprolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome)
- •Previous major uterine surgery (that would affect endometrial receptivity)
- •Secondary exclusion criteria
- •<5 follicles at the time of trigger
- •<2 full formed blastocyst on day 5 of embryo culture
结局指标
主要结局
embryo implantation rate
时间窗: 12 months
the number of fetal sacs per embryo transferred to a patient's uterus
次要结局
- oocyte maturation(12 months)
- Ovarian hyperstimulation syndrome(12 months)
研究者
Kevin Coetzee
Scientific Advisor
Antalya IVF