Prospective Study of an Human Endometrial Receptivity Test

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertile

Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Infertile patients associated with multiple implantation failures. Signatures consent and non-opposition letter. Patients with a standard infertility assessment. Patients with a monitored cycle (ultrasound, hormonal markers) during the mock frozen embryo transfer cycle to perform the Win-test and during the embryo transfer cycle. Patients with complete treatment information during the mock frozen embryo transfer cycle to perform the Win-test and during the embryo transfer cycle. Patients with accurate transfer day information. Patients for whom we have the outcome (pregnancy, live birth). Exclusion criteria: More than 24 weeks of amenorrhea

Ages Eligible for Study
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Minimum Age: 27 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RIF patients<br>Repeated implantation failure patients | |
| Oocyte/embryo donation program<br>Patients awaiting for oocyte/embryo-donation recipient patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Clinical pregnancy was defined as ultrasound visualization of a gestational sac with a positive embryo heartbeat | At 7-8 weeks of amenorrhea after customized timing of embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | Live birth rate was defined as a delivery with at least one live born baby of more than 24 weeks of amenorrhea | More than 24 weeks of amenorrhea | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial receptivity assessment for customized embryo transfer, Human Reproduction, ART, Endometrial receptivity