Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate

NCT ID: NCT02522806

Last Updated: 2019-11-18

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

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-23

Study Completion Date

2019-04-10

Brief Summary

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In spite of all progress realized in the field of assisted reproduction the pregnancy rate by In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle.

Different causes may account for these failures and that, during all stages of pregnancy.

Recent studies have investigated an essential step in fecundation : uterine receptivity. Some teams have shown that a lot of immunological factors would have very significant in this step, by them possible expression in this process. Other studies looked at genes modulation, essential to implantation, with endometrium manipulation, simple, such as endometrial biopsy (EB). The last findings published on this subject, but after 2 IVF failures, are most encouraging because the pregnancy rate for these teams after just endometrial local injury (EB after 2 IVF failures) is well above their usual pregnancy rate. Some teams have focused on immunoassay of endometrial biopsy, in order to profile uterine receptivity and suggest with results, suitable treatment for each patient (ongoing study).

EB is quick, easy, make in a simple consultation and with a low cost, contrary to immunological study, which depend of ultra-specialized laboratories and therefore with an important cost.

Detailed Description

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Conditions

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Sterility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A

Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle.

Group Type EXPERIMENTAL

endometrial biopsy

Intervention Type PROCEDURE

Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle

Group B

none endometrial biopsy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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endometrial biopsy

Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Only first IVF
* Acceptance of protocol by patient after free and complete information and signature of consent.
* Anti-Mullerian Hormone (AMH ) greater than 1
* Member or eligible to social security system
* Availabilities for a follow up 2 or 12 months.

Exclusion Criteria

* Known intolerance of proposed treatment
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne GENOD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01003-44

Identifier Type: OTHER

Identifier Source: secondary_id

1408062

Identifier Type: -

Identifier Source: org_study_id

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