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

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ClinicalTrials.gov Identifier: NCT02522806
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Sterility, Female Procedure: endometrial biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate
Actual Study Start Date : September 23, 2014
Actual Primary Completion Date : April 10, 2019
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Group A
Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle.
Procedure: endometrial biopsy
Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle

No Intervention: Group B
none endometrial biopsy



Primary Outcome Measures :
  1. number of Early pregnancy [ Time Frame: Day 28 ]

    Early pregnancy is defined by beta human chorionic gonadotropin (HCG)>100 mIU/ml defined by at least one rate of beta HCG>100 on the 3 possible dosages after embryo transfer (if first dosage negative or >100 : stop, if first dosage positive but <100 : Second dosing, if >100 or less than first result : stop, otherwise third dosing).

    Endometrial biopsy (diameter : 1mm ; length : 5mm) with use a pipelle, in the second part of the cycle between J17 and J22 during cycle before IVF



Secondary Outcome Measures :
  1. Number of middle pregnancy [ Time Frame: 5 weeks of amenorrheas. ]
    Middle pregnancy is defined by an intra uterine gestation sac on echography of 5 or 6 weeks of amenorrheas.

  2. Number of late pregnancy [ Time Frame: 12 weeks of amenorrheas. ]
    Late pregnancy is defined by an intra uterine evolutionary pregnancy on echography of 12 weeks of amenorrheas.

  3. number of Live birth [ Time Frame: delivery ]
  4. number of patient with endometrial chronic infection [ Time Frame: Day 22 of previous cycle of IVF ]
    Presence of endometrial chronic infection is measured by histopathologic analysis of biopsy

  5. number of patient with pain [ Time Frame: Day 22 of previous cycle of IVF ]
    Pain is estimated by visual analogue scale note at the end of biopsy (day 22 of previous cycle of IVF)

  6. number of patient with endometrial acute infection [ Time Frame: Day 24 of previous cycle of IVF ]
    An endometrial acute infection is defined by pelvic spontaneous pain and/or leucorrhoea, abnormal metrorrhagia and/or fever appearing after biopsy.

  7. number of patient with uterine perforation [ Time Frame: Day 22 of previous cycle of IVF ]
    An uterine perforation is defined by intense pain at the time of the biopsy or in the days to come and/or leucorrhoea, abnormal metrorrhagia and/or fever.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522806


Locations
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France
CHU de SAINT-ETIENNE
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Anne GENOD, MD CHU de SAINT-ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02522806    
Other Study ID Numbers: 1408062
2014-A01003-44 ( Other Identifier: ANSM )
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Endometrial biopsy
previous ovarian hyperstimulation cycle
first IVF
antagonist protocol
clinical pregnancy rate
Additional relevant MeSH terms:
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Infertility
Infertility, Female