Win-Test: Prospective Study of an Human Endometrial Receptivity Test
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| RIF patients Repeated implantation failure patients |
|
| Oocyte/embryo donation program Patients awaiting for oocyte/embryo-donation recipient patients |
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uhmontpellier | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
- Merck Serono (GFI)
Investigators
- Principal Investigator: Samir Hamamah, University Hospital, Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL19_0590