Prospective Study of an Human Endometrial Receptivity Test

Infertile Clinical Trial

— Win-Test  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192396
• Other study ID #: RECHMPL19_0590
• Status: Completed
• Start date: July 1, 2012
• Est. completion date: May 25, 2019

Study information

• Verified date: December 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: May 25, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 27 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertile
• Infertility

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Merck Serono (GFI)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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