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

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.

Study Overview

• Status: Completed
• Conditions: Sterility, Female
• Intervention / Treatment: Procedure: endometrial biopsy

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of middle pregnancy	Middle pregnancy is defined by an intra uterine gestation sac on echography of 5 or 6 weeks of amenorrheas.	5 weeks of amenorrheas.
Number of late pregnancy	Late pregnancy is defined by an intra uterine evolutionary pregnancy on echography of 12 weeks of amenorrheas.	12 weeks of amenorrheas.
number of Live birth		delivery
number of patient with endometrial chronic infection	Presence of endometrial chronic infection is measured by histopathologic analysis of biopsy	Day 22 of previous cycle of IVF
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)	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.	Day 24 of previous cycle of IVF
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.	Day 22 of previous cycle of IVF

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Anne GENOD, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2014
• Primary Completion (Actual): April 10, 2019
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Endometrial biopsy; previous ovarian hyperstimulation cycle; first IVF; antagonist protocol; clinical pregnancy rate
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 1408062; 2014-A01003-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No