Prospective Study of an Human Endometrial Receptivity Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-01

Study Completion Date

2019-05-25

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.

Detailed Description

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Conditions

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Infertile

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RIF patients

Repeated implantation failure patients

No interventions assigned to this group

Oocyte/embryo donation program

Patients awaiting for oocyte/embryo-donation recipient patients

No interventions assigned to this group

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

Minimum Eligible Age

27 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samir Hamamah

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

References

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Haouzi D, Entezami F, Torre A, Innocenti C, Antoine Y, Mauries C, Vincens C, Bringer-Deutsch S, Gala A, Ferrieres-Hoa A, Ohl J, Gonzalez Marti B, Brouillet S, Hamamah S. Customized Frozen Embryo Transfer after Identification of the Receptivity Window with a Transcriptomic Approach Improves the Implantation and Live Birth Rates in Patients with Repeated Implantation Failure. Reprod Sci. 2021 Jan;28(1):69-78. doi: 10.1007/s43032-020-00252-0. Epub 2020 Jul 28.

Reference Type DERIVED

PMID: 32725589 (View on PubMed)

Other Identifiers

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RECHMPL19_0590

Identifier Type: -

Identifier Source: org_study_id