IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.
详细描述
Study design:
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. .
Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD).
vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 38 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 38 and 42 years. Sperm: use of donor sperm or husband sperm reaching WHO criteria 2010.
排除标准
- •Tubal infertility (even one tube).
- •Major uterine or ovarian abnormalities
- •Metabolic abnormalities
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 12 weeks
Study design: Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD). vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol. Primary endpoint: Comparison of the cumulative ongoing pregnancy rates after 3 IUI cycles versus 1 IVF/ICSI cycle.
次要结局
未报告次要终点
研究者
Michael De Brucker
MD
Universitair Ziekenhuis Brussel