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临床试验/NCT03152643
NCT03152643已完成不适用

Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer: A Multicenter, Prospective, Randomized Controlled Trial

The First Affiliated Hospital with Nanjing Medical University11 个研究点 分布在 1 个国家目标入组 992 人开始时间: 2018年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
992
试验地点
11
主要终点
cumulative live birth rate

研究概览

简要总结

The aim of this RCT is to compare differences in the efficacy and safety between cleavage-stage embryo transfer and blastocyst-stage embryo transfer in IVF/ICSI treatment cycle, taking into account of subsequent vitrified embryo transfers. Subjects with 3 or more transferrable cleavage embryos will be randomized to the cleavage-stage or blastocyst-stage embryos transfer group. The primary outcome is cumulative live birth rate (CLBR) per patient until the first live birth from one initiated oocyte retrieval cycle, calculated using outcomes from the first three embryo transfers within 1 year after randomization.

详细描述

This is a multicenter, randomized clinical trial comparing the efficacy and safety between cleavage-stage embryo transfer and blastocyst-stage embryo transfer in IVF/ICSI treatment cycle, taking into account of subsequent vitrified embryo transfers.Randomization will be performed on day 2/3 after oocyte retrieval, when at least 3 embryos are achieved. Patients in group A will have 1 cleavage-stage embryo transferred. Patients in group B will have 1 blastocyst-stage embryo transferred. The outcomes from all the embryo transfers within 1 year after randomization will be followed up. If a pregnancy/live birth is not achieved, single embryo transfer is required for the first 3 embryo transfers within 1 year after randomization. For embryo transfers beyond the third within the 1 year, patient's treatment must follow their randomized allocation, and SET is no longer mandatory. The follow-up period is 2 years from the day of randomization.Due to the COVID-19 pandemic, the participants who were unable to undergo the embryo transfers in 1 year of randomization will have 3 months extension for frozen embryo transfer. The follow-up for these participants will be extended for 3 months as well.

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

cumulative live birth rate

时间窗: 30 months

Cumulative live birth rate (CLBR) is defined the first live birth per patient from one initiated oocyte retrieval cycle(Calculated using outcomes from the first three embryo transfers within 1 year after randomization). Live birth is defined as delivery of any neonate ≥24 weeks gestation with heart beat and breath.

次要结局

  • congenital anomalies(30 months)
  • Birth weight(30 months)
  • moderate or severe OHSS rate(12 months)
  • ectopic pregnancy(24 months)
  • incidence of obstetric and perinatal complications(30 months)
  • clinical pregnancy rate(30 months)
  • ongoing pregnancy rate(30 months)
  • Pregnancy loss rate(30 months)
  • biochemical pregnancy rate(30 months)
  • sex ratio(30 months)
  • multiple pregnancy(30 months)
  • implantation rate(30 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

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