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临床试验/NCT04192396
NCT04192396已完成不适用

Prospective Study of the 'Win Test', a New Diagnostic Tool to Assess Human Endometrial Receptivity Under Natural Cycle or Hormone Replacement Therapy

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2012年7月1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
217
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

Evaluation of endometrial receptivity is a crucial step in in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) programs. Using "Omic technologies", such as transcriptomic and proteomic analyses, the investigators previously identified a specific molecular signature of human endometrial receptivity during the embryo implantation window. After validation of this signature in fertile women and in an ex vivo model (i.e., stromal and epithelial endometrium cells),the investigatorsdeveloped a diagnostic tool called Win-Test (Window Implantation Test) to evaluate the expression level of a set of endometrial receptivity-specific genes during the implantation window by quantitative RT-PCR. Based on their expression, each endometrial biopsy sample can be classified as receptive, partially receptive or non-receptive. Then, after the identification of the right cycle day within the implantation window where endometrium is considered as receptive, a customized timing for embryo transfer with respect of the synchronization of the embryo-maternal dialogue must be performed. A prospective study to validate the relevance of the Win-Test, is a necessary step to gauge its effectiveness. In this objective, patients with multiple implantation failures will be recruited. Embryo transfers were performed in double-arm: the intervention group had a customized timing of embryo transfer according to the Win-Test strategy and recommendation, the control group had their embryos transferred in a classical timing. Pregnancy and live birth rates (LBR) were compared between groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
27 Years 至 48 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

Clinical pregnancy rate

时间窗: At 7-8 weeks of amenorrhea after customized timing of embryo transfer

Clinical pregnancy was defined as ultrasound visualization of a gestational sac with a positive embryo heartbeat

次要结局

  • Live birth rate(More than 24 weeks of amenorrhea)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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