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

Primary Purpose

Sterility, Female

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
endometrial biopsy
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sterility, Female focused on measuring Endometrial biopsy, previous ovarian hyperstimulation cycle, first IVF, antagonist protocol, clinical pregnancy rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • CHU de SAINT-ETIENNE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

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

none endometrial biopsy

Outcomes

Primary Outcome Measures

number of Early pregnancy
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

Number of middle pregnancy
Middle pregnancy is defined by an intra uterine gestation sac on echography of 5 or 6 weeks of amenorrheas.
Number of late pregnancy
Late pregnancy is defined by an intra uterine evolutionary pregnancy on echography of 12 weeks of amenorrheas.
number of Live birth
number of patient with endometrial chronic infection
Presence of endometrial chronic infection is measured by histopathologic analysis of biopsy
number of patient with pain
Pain is estimated by visual analogue scale note at the end of biopsy (day 22 of previous cycle of IVF)
number of patient with endometrial acute infection
An endometrial acute infection is defined by pelvic spontaneous pain and/or leucorrhoea, abnormal metrorrhagia and/or fever appearing after biopsy.
number of patient with uterine perforation
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.

Full Information

First Posted
August 12, 2015
Last Updated
November 14, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02522806
Brief Title
Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate
Acronym
BEONE
Official Title
Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 23, 2014 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sterility, Female
Keywords
Endometrial biopsy, previous ovarian hyperstimulation cycle, first IVF, antagonist protocol, clinical pregnancy rate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
none endometrial biopsy
Intervention Type
Procedure
Intervention Name(s)
endometrial biopsy
Intervention Description
Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle
Primary Outcome Measure Information:
Title
number of Early pregnancy
Description
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
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Number of middle pregnancy
Description
Middle pregnancy is defined by an intra uterine gestation sac on echography of 5 or 6 weeks of amenorrheas.
Time Frame
5 weeks of amenorrheas.
Title
Number of late pregnancy
Description
Late pregnancy is defined by an intra uterine evolutionary pregnancy on echography of 12 weeks of amenorrheas.
Time Frame
12 weeks of amenorrheas.
Title
number of Live birth
Time Frame
delivery
Title
number of patient with endometrial chronic infection
Description
Presence of endometrial chronic infection is measured by histopathologic analysis of biopsy
Time Frame
Day 22 of previous cycle of IVF
Title
number of patient with pain
Description
Pain is estimated by visual analogue scale note at the end of biopsy (day 22 of previous cycle of IVF)
Time Frame
Day 22 of previous cycle of IVF
Title
number of patient with endometrial acute infection
Description
An endometrial acute infection is defined by pelvic spontaneous pain and/or leucorrhoea, abnormal metrorrhagia and/or fever appearing after biopsy.
Time Frame
Day 24 of previous cycle of IVF
Title
number of patient with uterine perforation
Description
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.
Time Frame
Day 22 of previous cycle of IVF

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne GENOD, MD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate

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