Clinical trial NCT02522806: Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate
Official title: Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sterility, Female
Keywords: Endometrial biopsy
previous ovarian hyperstimulation cycle
first IVF
antagonist protocol
clinical pregnancy rate
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 315
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: number of Early pregnancy
timeFrame: Day 28
Secondary outcomes:
measure: Number of middle pregnancy
timeFrame: 5 weeks of amenorrheas.
measure: Number of late pregnancy
timeFrame: 12 weeks of amenorrheas.
measure: number of Live birth
timeFrame: delivery
measure: number of patient with endometrial chronic infection
timeFrame: Day 22 of previous cycle of IVF
measure: number of patient with pain
timeFrame: Day 22 of previous cycle of IVF
measure: number of patient with endometrial acute infection
timeFrame: Day 24 of previous cycle of IVF
measure: number of patient with uterine perforation
timeFrame: Day 22 of previous cycle of IVF
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Anne GENOD, MD
role: PRINCIPAL_INVESTIGATOR
References: