Gonadotropin Releasing Hormone Agonist for Luteal Phase Support in Gonadotropin Releasing Hormone Antagonist Protocol Cycles
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following GnRH antagonist protocol
详细描述
Endometrial preparation for embryo transfer (ET) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. The patients will be randomly divided into 2 groups for luteal phase support: (i) Group A (GnRHa group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval, and (ii) Group B (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after ET
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.
排除标准
- •Moderate or severe endometriosis.
- •Hydrosalpinx.
- •Uterine abnormalities.
- •Previous uterine surgery.
研究组 & 干预措施
GnRHa group
Luteal phase SC administration of a single dose (0.2 mg) of GnRHa (Triptorelin)
干预措施: Triptorelin (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 6 weeks after embryo transfer
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
次要结局
- Miscarriage rate(12 weeks gestational age)
- Implantation rate(6 weeks after embryo transfer)
研究者
Mohamed Sayed Abdelhafez
Dr
Mansoura University