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Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate (BEONE)

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Sterility, Female

Treatments

Procedure: endometrial biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02522806
2014-A01003-44 (Other Identifier)
1408062

Details and patient eligibility

About

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.

Enrollment

315 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

315 participants in 2 patient groups

Group A
Experimental group
Description:
Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle.
Treatment:
Procedure: endometrial biopsy
Group B
No Intervention group
Description:
none endometrial biopsy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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