Dual Trigger With GnRH Agonist and Human Chorionic Gonadotropin for Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- numbers of patients having OHSS
研究概览
简要总结
Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients.
However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.
Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with polycystic ovarian syndrome
- •patients with polycystic ovarian morphology on ultrasound
- •patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins
排除标准
- •patients undergoing coasting
- •patients with past ovarian surgery
研究组 & 干预措施
0.2mg triptorelin and 1000 IU hCG
Patients were triggered with 0.2mg triptorelin and 1000 IU hCG
干预措施: hCG (Drug)
0.2mg triptorelin and 500 IU hCG
Patients were triggered with 0.2mg triptorelin and 500 IU hCG
干预措施: triptorelin (Drug)
0.2mg triptorelin and 500 IU hCG
Patients were triggered with 0.2mg triptorelin and 500 IU hCG
干预措施: hCG (Drug)
0.2mg triptorelin and 1000 IU hCG
Patients were triggered with 0.2mg triptorelin and 1000 IU hCG
干预措施: triptorelin (Drug)
结局指标
主要结局
numbers of patients having OHSS
时间窗: 2 weeks post trigger with dual GnRHa
clinical pregnancy rate per transfer cycle
时间窗: 1month post embryo transfer
oocyte yield
时间窗: oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)
Oocyte yield was defined as the ratio of the total number of collected oocytes to the number of follicles measuring ≥10 mm on the day of oocyte retrieval.
Oocyte maturity
时间窗: 24 hours post oocyte retrieval day
Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with intracytoplasmic sperm injection (ICSI).
次要结局
- serum hCG level 12 hours post trigger(12 hours post trigger)
- fertilization rate(48 hours post IVF/ICSI)
- implantation rate(1 month post embryo transfer)
- serum luteinizing hormone level 12 hours post trigger(12 hours post trigger)
研究者
Chenshiling
Professor, M.D., Ph.D.
Nanfang Hospital, Southern Medical University