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Clinical Trials/NCT04192396
NCT04192396
Completed
Not Applicable

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 site in 1 country217 target enrollmentJuly 1, 2012
ConditionsInfertile

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertile
Sponsor
University Hospital, Montpellier
Enrollment
217
Locations
1
Primary Endpoint
Clinical pregnancy rate
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2012
End Date
May 25, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Clinical pregnancy rate

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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