Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate

Study Overview
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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.

Official Title
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Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate

Conditions
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Sterility, Female

Intervention / Treatment
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* Procedure: endometrial biopsy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle. | Procedure: endometrial biopsy<br>* Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle<br>|
| No Intervention: Group B<br>none endometrial biopsy | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial biopsy, previous ovarian hyperstimulation cycle, first IVF, antagonist protocol, clinical pregnancy rate