'A Multicentre, Prospective Randomized Study to Assess the Effect When GnRH Antagonist is Started Either on Stimulation Day 1 and Day 6 vs. Conventional GnRH Agonist Long Protocol in Patients With Polycystic Ovary Syndrome Undergoing IVF-ET
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- number of oocyte retrieved
研究概览
简要总结
GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been accomplished by several randomized controlled trials compared with conventional GnRH agonist long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is to investigate the laboratory and clinical priority during ovarian stimulation for IVF in patients with PCOS treated with three different protocols.
详细描述
GnRH Antagonist is Started on Stimulation Day 1 GnRH Antagonist is Started on Stimulation Day 6 Conventional GnRH Agonist Long Protocol
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
- None
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
- •PCOS patients (diagnosed as 2003 ASRM(The American Society for Reproductive Medicine)/ESHRE(The European Society of Human Reproduction and Embryology) consensus meeting guideline)
- •age 20-40 years
- •patients who have normal uterus
- •Korean ethnicity
排除标准
- •patients who have abnormal thyroid function
- •patients who have abnormal prolactin test
- •patients who have diabetes, or Cushing's syndrome, or congenital adrenal hyperplasia, or androgen-producing tumor.
- •Patients who reject informed consent
- •patients who have experience of adverse events for GnRH agonist, antagonist, recombinant FSH(follicle-stimulating hormone).
研究组 & 干预措施
GnRH antagonist, SD #1 starting group
Start GnRH antagonist from stimulation day 1 during ovulation induction cycles
干预措施: GnRH antagonist (Cetrorelix) (Drug)
GnRH antagonist, SD #6 starting group
Start GnRH antagonist from stimulation day 6 during ovulation induction cycles
干预措施: GnRH antagonist (Cetrorelix) (Drug)
Conventional GnRH agonist long group
Conventional GnRH agonist long protocol
干预措施: Conventional GnRH agonist (Triptorelin) (Drug)
结局指标
主要结局
number of oocyte retrieved
时间窗: ovum pick up day, At the point of ovum pick-up, we can count how many oocyte was retrieved. So, almost just after ovum pick-up, outcome measure will be possible.
次要结局
- pregnancy rate(after confirming fetal heart beat via transvaginal ultrasound. Usually 2~4 weeks after ovum pick-up day.)
研究者
Young Min Choi
Young Min Choi
Seoul National University Hospital