Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients Undergoing Ovarian Stimulation for IVF With GnRH Antagonists and Recombinant FSH.
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Percentage of mature oocytes retrieved
研究概览
简要总结
The present study aims to investigate whether the dosage of the GnRH agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and recombinant FSH.
详细描述
Three different doses of GnRH agonist (0.1mg, 0.2mg or 0.4 mg) will be used randomly to trigger final oocyte maturation. The primary outcome measure will be the percentage of mature oocytes retrieved.
Secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles >11mm in diameter on the day of triggering), fertilization rates and OHSS occurrence.
Serum LH, FSH, E2, PRG levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing ovarian stimulation for IVF using GnRH antagonist protocol
- •Age < 40 years
- •Anticipated high ovarian response
排除标准
- •Endometriosis > than grade II
- •One ovary
研究组 & 干预措施
0.4 mg triptorelin
0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin
干预措施: 0.4 mg triptorelin (Drug)
0.2 mg triptorelin
0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin
干预措施: 0.2 mg triptorelin (Drug)
0.1 mg triptorelin
0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin
干预措施: 0.1 mg triptorelin (Drug)
结局指标
主要结局
Percentage of mature oocytes retrieved
时间窗: 36 hours post GnRH agonst administration
Percentage of mature oocytes retrieved following oocyte retrieval
次要结局
- oocyte recovery rate(36 hours post GnRH agonist administration)
- Duration of luteal phase(16 days)
- total number of oocytes retrieved(36 hours post GnRH agonist administration)
- Fertilization rate(Day 1 post oocyte retrieval)
- Serum LH, FSH, E2, PRG levels(8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration)
- OHSS occurrence(16 days post triggering)
研究者
E.M. Kolibianakis
Ass Professor in Obstetrics - Gynecology and Assisted Reproduction
Aristotle University Of Thessaloniki