A Randomized Clinical Trial Comparing Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 260
- 主要终点
- Cumulative live birth rate
研究概览
简要总结
To compare the difference in cumulative live birth rates between dual ovarian stimulation and two antagonist stimulations in poor ovarian responders.
详细描述
Studies have shown the ability to obtain oocytes with equivalent quality from the follicular and the luteal phase, and a higher number of oocytes within one cycle when using dual ovarian stimulation (duostim). This could be particularly relevant for women with poor ovarian responders (POR). Whether the cumulative live birth rates differ after duostim and two antagonist stimulations in POR remains controversial.
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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with POR were defined with adjusted Bologna criteria, at least two of the three following criteria: advanced maternal age (40 years); 3 oocytes in previous IVF; and antral follicle count (AFC) 5 and/or anti-Mu¨llerian hormone (AMH) 1.1 ng/ml (this criterion was mandatory)
- •Aged from 20 to 44 years
- •Body mass index (BMI) from 19 to 32 kg/m2
- •No more than two previous IVF cycles were recruited
排除标准
- •Amenorrhoea
- •Follicle stimulating hormone (FSH) 20 IU/L or AFC 1
- •Women with a partner with an extremely severe sperm anomaly or sperm donor use
结局指标
主要结局
Cumulative live birth rate
时间窗: 36 months
Live birth is defined as the delivery of any alive infant after 22 weeks of gestation after our interventions, and cumulative live birth rate is calculated by the total number of women randomized to the specific group.
次要结局
- Total amount of Gn used during ovarian stimulation(24 months)
- Number of retrieved oocytes(24 months)
- Clinical pregnancy rate(36 months)
- Time to live birth (TTLB)(36 months)