Sterility, Female
Conditions
Keywords
Endometrial biopsy, previous ovarian hyperstimulation cycle, first IVF, antagonist protocol, clinical pregnancy rate
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.
Interventions
PROCEDUREendometrial biopsy
Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of Early pregnancy | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of late pregnancy | 12 weeks of amenorrheas. | Late pregnancy is defined by an intra uterine evolutionary pregnancy on echography of 12 weeks of amenorrheas. |
| number of Live birth | delivery | — |
| number of patient with endometrial chronic infection | Day 22 of previous cycle of IVF | Presence of endometrial chronic infection is measured by histopathologic analysis of biopsy |
| Number of middle pregnancy | 5 weeks of amenorrheas. | Middle pregnancy is defined by an intra uterine gestation sac on echography of 5 or 6 weeks of amenorrheas. |
| number of patient with endometrial acute infection | 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. |
| number of patient with uterine perforation | 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. |
| number of patient with pain | 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) |
Countries
France
Outcome results
None listed