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临床试验/NCT03381001
NCT03381001已完成不适用

Influence of Post-thaw Embryo Culture Interval Before Embryo Transfer on Assisted Reproduction Success Rates

Federal University of Minas Gerais2 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2017年6月15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
268
试验地点
2
主要终点
pregnancy rates

研究概览

简要总结

The transfer of frozen / thawed embryos has been routinely performed in the last 30 years as part of Assisted Reproduction treatment (ART). Currently, more than 50% of couples submitted to ART have surplus embryos eligible for freezing followed by transfer in subsequent cycles. Therefore the selection criteria for the thawed embryos to be transferred must be rigorous in order to maximize pregnancy and of live birth rates. Usually, the evaluation of the embryos before transfer can be performed based on blastomeres survival after a short culture period between thaw and embryos transfer, i.e., 2 to 5 hours, or based on embryo development over a prolonged period of culture (18h to 24h). Post-thaw embryo culture might have an impact on the recovery of mitosis and normal cellular functions. However, until now, there is no consensus in the literature on which post-thaw culture interval has a better impact on pregnancy and live birth rates. Also, blastocysts formation after freezing/thawing of embryos at cleavage stage may bring relevant information about post-thaw culture. Moreover, this strategy can be used as an alternative treatment. Therefore, the authors proposed this prospective randomized, triple-blind study to evaluate the impact of post-thaw embryo culture on the pregnancy and live birth rates.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients submitted to ART treatment due to infertility that had frozen embryos and need an embryo transfer after endometrial preparation and embryo thawing

排除标准

  • patients that does not reach criteria for frozen embryo transfer (thin endometrium, bleeding, inappropriate use of hormones)
  • difficult embryo transfer
  • embryos that were frozen twice

研究组 & 干预措施

embryo transfer after embryo thaw

Active Comparator

Embryos will be transferred at the same day of the thawing procedure

干预措施: embryo transfer with no culture (Procedure)

embryo transfer after thaw and culture

Experimental

Embryos will be transferred one day after thawing procedure

干预措施: embryo transfer after thaw and culture (Procedure)

结局指标

主要结局

pregnancy rates

时间窗: 8 weeks

percentage of patients that become pregnant after Frozen embryo transfer

次要结局

  • implantation rate(6 weeks)
  • embryo development(24 hours)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selmo Geber

Professor

Federal University of Minas Gerais

研究点 (2)

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