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Prospective Study of an Human Endometrial Receptivity Test

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04192396
Acronym
Win-Test
Enrollment
217
Registered
2019-12-10
Start date
2012-07-01
Completion date
2019-05-25
Last updated
2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertile

Keywords

Endometrial receptivity assessment for customized embryo transfer, Human Reproduction, ART, Endometrial receptivity

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.

Interventions

None listed

Sponsors

Merck Serono (GFI)
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
27 Years to 48 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rateAt 7-8 weeks of amenorrhea after customized timing of embryo transferClinical pregnancy was defined as ultrasound visualization of a gestational sac with a positive embryo heartbeat

Secondary

MeasureTime frameDescription
Live birth rateMore than 24 weeks of amenorrheaLive birth rate was defined as a delivery with at least one live born baby of more than 24 weeks of amenorrhea

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026