Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 388
- 试验地点
- 2
- 主要终点
- Pregnancy rate
研究概览
简要总结
Single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs) improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.
详细描述
Embryos from in vitro fertilization are routinely transferred into the woman's uterus at cleavage stage (Day 2 to 3) or at blastocyst stage (Day 5 to 6).
The rational of blastocyst stage transfer is that blastocyst stage is the most biologically correct stage for embryos to be in the uterus, and longer culture in the laboratory may give the possibility to reduce the number of genetically abnormal embryos.
The investigators design a single center randomized trial, including 388 women aged less than 39 years, performing in vitro fertilization, to confront blastocyst stage embryo transfers (ETs) and cleavage stage ETs. Each patient is randomized with a non blind randomization, based on a computer model, on the first day after fertilization.
The primary outcomes are implantation and pregnancy rate. The secondary outcome is to verify if blastocyst embryo transfer leads to a higher multiple-pregnancy rate.
An interim analysis takes place at one third of the population. Follow up is of 4 weeks for implantation rate, and covers 8 weeks regarding pregnancy rate.
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
- 18 Years 至 38 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female patients undergoing IVF procedures
- •age less than 39 years
排除标准
- •less than 4 fertilized eggs in day 1 after IVF
结局指标
主要结局
Pregnancy rate
时间窗: 8 weeks after inclusion
Number of patients achieving a clinical pregnancy divided for embryo transfers
次要结局
- Implantation rate(4 weeks after inclusion)
- Multiple pregnancy rate(8 weeks after inclusion)
