Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rates
研究概览
简要总结
This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment
详细描述
Poor responders to ovarian stimulation for IVF may be either predicted or evidenced from previous treatment. The ESHRE criteria for poor responders will be used to select candidates for this trial. A power calculation determined that 200 subjects should be recruited to each arm to receive either DHEA or placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Markers for poor ovarian reserve (AMH <7 pmol/L(<1.1 ng/ml) and/or AFC< 7)
- •Previous poor response to ovarian stimulation ( ≤3 oocytes with a conventional stimulation protocol)
排除标准
- •Women > 42 years
- •Women with premature ovarian failure / premature menopause (FSH>40 U/L). Women already taking DHEA.
- •Patients with a known allergy to the trial drug or any of the active ingredients in the placebo.
研究组 & 干预措施
Teatment
75mg Dehydroepiandrosterone once daily for minimum ten weeks prior to starting ovarian stimulation
干预措施: Dehydroepiandrosterone (Drug)
Comaprator
75mg placebo once daily for minimum ten weeks prior to starting ovarian stimulation
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical pregnancy rates
时间窗: at 6-8 weeks gestation
ultrasound confirmation of a foetus with a heartbeat
次要结局
未报告次要终点