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Completed

NCT Number: NCT04192396

Prospective Study of an Human Endometrial Receptivity Test

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.

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Key information

Age range

27 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 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 outcomes

  1. Live birth rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Merck Serono (GFI)

Registry information

Official study title

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

Acronym: Win-Test

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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