Embryo Culture at a Constant Temperature of 36.6°C or 37.1°C: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Clinical pregnancy
研究概览
简要总结
On the day of oocyte retrieval, participants will be randomized to stable culture at 37.1°C or 36.6°C with the ultimate aim of finding a difference in clincial pregnancies.
详细描述
A previous study in our centre analysed stable embryo culture at 36.6°C and 37.1°C, on sibling oocytes. The primary aim was to analyse possible differneces in embryo development (utilization rate) up to day 5/6. In this study, the investigators found a high difference in clinical pregnancy rate between both groups (46.4% versus 77.4%). Since this study was not powered to find differences in clincial pregnancy rates between both groups, this RCT was especially powered as a superiority trial to find differences in clincial pregnancy rates between both groups. On the day of oocyte retrieval, patients will be allocated to culture at one of both temperatures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Day 5 transfer
- •Single embryo transfer
- •Only ejaculated sperm (fresh or frozen, autologous or heterologous)
- •Age <40 years
- •Cycle rank <3 for the current child
- •Last ultrasound: 8 follicles of at least 12 mm
- •At least 6 mature oocytes
排除标准
- •IVF versus ICSI
- •Failed fertilization in previous cycle
- •no previous cycle without embryo transfer
- •No use of Ca ionophores for embryo quality or fertilization problems
结局指标
主要结局
Clinical pregnancy
时间窗: 7 weeks
ultrasound: sac and fetal heartbeat positive
次要结局
- Fertilization rate(1 day)
- live birth rate of the fresh cycle(43 weeks)
- embryo development/utilization rate(6 days)
- cumulative live birth rate per cycle(104 weeks)
研究者
Neelke De Munck
PhD
Universitair Ziekenhuis Brussel