Prospective Study of an Human Endometrial Receptivity Test

Completed

• Conditions: Infertile

• Registration Number: NCT04192396
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-25
• Status Verified: 2019-12
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-10
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 217

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	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 Outcome Measures

Name	Time	Method
Live birth rate	More than 24 weeks of amenorrhea	Live birth rate was defined as a delivery with at least one live born baby of more than 24 weeks of amenorrhea

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France