Comparative Study Between the Use of Corifollitropin Alfa and Daily Recombinant FSH in the Controlled Ovarian Stimulation of Poor Responders
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Number of mature oocytes (metaphase II)
研究概览
简要总结
A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Advanced maternal age (≥40 years)
- •A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
- •An abnormal ovarian reserve test (i.e. antral follicle count <5-7 follicles or anti-mullerian hormone level <0.5-1.1 ng/ml)
排除标准
- 未提供
研究组 & 干预措施
Group 1
First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator)
干预措施: Corifollitropin alfa (Drug)
Group 2
First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental)
干预措施: Corifollitropin alfa (Drug)
结局指标
主要结局
Number of mature oocytes (metaphase II)
时间窗: 1 year
Number of mature oocytes (metaphase II) obtained after the follicle puncture
次要结局
- Total number of oocytes(1 year)
- Symptoms associated with the ovarian stimulation protocol(1 year)
- Patient perception of the stimulation treatment(1 year)
- Length of the stimulation treatment(1 year)
- Number of subcutaneous injections(1 year)