Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate

Sterility, Female Clinical Trial

— BEONE  

Official title:

Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522806
• Other study ID #: 1408062
• Secondary ID: 2014-A01003-44
• Status: Completed
• Phase: N/A
• Start date: September 23, 2014
• Est. completion date: April 10, 2019

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Sterility, Female

Intervention

Procedure:
• endometrial biopsy
Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	number of Live birth		delivery
Secondary	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
Secondary	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
Secondary	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
Secondary	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