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临床试验/NCT03201783
NCT03201783已完成不适用

A Randomized Trial Comparing the Effect of Immediate Versus Delayed Frozen-thawed Embryo Transfer Following a Stimulated IVF Cycle

ShangHai Ji Ai Genetics & IVF Institute1 个研究点 分布在 1 个国家目标入组 724 人开始时间: 2017年8月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
724
试验地点
1
主要终点
ongoing pregnancy

研究概览

简要总结

Information regarding the optimal timing for frozen-thawed embryo transfer (FET) following a stimulated in vitro fertilization (IVF) is lacking. One option is to perform FET in the first cycle following the stimulated IVF cycle, i.e. immediate transfer. Another option is to postpone FET for at least one menstrual cycle, i.e. delayed transfer. This randomized study aims to compare the ongoing pregnancy rate of immediate versus delayed FET following a stimulated IVF cycle.

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

盲法说明

No masking because of the nature of the intervention

入排标准

年龄范围
20 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women aged ≤43 years at the time of IVF/ICSI treatment Undergoing IVF with a standard stimulation At least one frozen embryo or blastocyst The first FET cycle following ovarian stimulation in IVF/ICSI

排除标准

  • •Use of mild stimulation or natural cycle for IVF/ICSI treatment Severe ovarian hyperstimulation syndrome during IVF/ICSI treatment Preimplantation genetic diagnosis treatment Use of donor oocytes Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation

研究组 & 干预措施

immediate group

Other

the intervention: immediate frozen-thawed embryo transfer (FET) which means FET will be performed in the first cycle following the stimulated IVF cycle

干预措施: immediate frozen-thawed embryo transfer (Other)

delayed group

Other

the intervention: delayed frozen-thawed embryo transfer (FET) which means FET will be performed at least in the second cycle following the stimulated IVF cycle

干预措施: delayed frozen-thawed embryo transfer (Other)

结局指标

主要结局

ongoing pregnancy

时间窗: viable pregnancy beyond gestation 12 weeks

viable pregnancy beyond gestation 12 weeks

次要结局

  • miscarriage(the loss of a pregnancy before 22 weeks gestation)
  • Positive hCG level(A blood pregnancy test is performed 14 days after the FET)
  • clinical pregnancy(presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy)
  • biochemical pregnancy:(positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation)
  • implantation rate(number of gestational sacs per embryo transferred during 4 weeks of pregnancy)
  • multiple pregnancy(multiple pregnancy beyond gestation 12 weeks)
  • ectopic pregnancy(ectopic pregnancy during 12 weeks gestation)
  • live birth rate(a live birth after 22 weeks gestation)
  • birth weight(a live birth after 22 weeks gestation)

研究者

发起方
ShangHai Ji Ai Genetics & IVF Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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