Evaluating the Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos at Royan Institute: A Phase 3, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Pregnancy Rate
研究概览
简要总结
Recent improvements in cell culture systems have led to a shift in in vitro fertilization (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer. Blastocyst culture and transfer could theoretically provide better synchronization between the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy rates and implantation rate following transfer of thawed cleavage embryos and blastocysts cultured from thawed cleavage embryos.
详细描述
The proposal of this study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into two groups of thawed cleavage embryo transfers and transfers of blastocysts from thawed cleavage embryos. Embryos will be transferred in hormone replacement cycles. Preparation of the endometrium will be started in the second day of menstruation and will be continued according to their transfer type (blastocyst or cleavage). βhCG will be assessed 14 days after embryo transfer. Treatment cycle outcomes will be compared between 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 37 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients with first type of infertility
- •Age ≤ 37 years
- •Long ovulation induction protocol
排除标准
- •Any previous surgery on the uterus and ovaries
- •Uterine factor infertility
- •Sever Male factor infertility (TESE, TESA ،Oligoteratozoospermia)
- •Recurrent abortion
- •The women with poor ovarian reserve
结局指标
主要结局
Pregnancy Rate
时间窗: 4weeks
Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET).
次要结局
- Implantation Rate(14 days)
- Ongoing pregnancy rate(14 days)
- Miscarriage Rate(14 days)