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Completed

NCT Number: NCT02522806

Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate

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.

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Key information

Conditions

Sterility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endometrial biopsy

Procedure

Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle

Primary outcomes

  1. number of Early pregnancy

    Time frame: 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 outcomes

  1. Number of middle pregnancy

    Time frame: 5 weeks of amenorrheas.

    Middle pregnancy is defined by an intra uterine gestation sac on echography of 5 or 6 weeks of amenorrheas.

  2. Number of late pregnancy

    Time frame: 12 weeks of amenorrheas.

    Late pregnancy is defined by an intra uterine evolutionary pregnancy on echography of 12 weeks of amenorrheas.

  3. number of Live birth

    Time frame: delivery

  4. number of patient with endometrial chronic infection

    Time frame: Day 22 of previous cycle of IVF

    Presence of endometrial chronic infection is measured by histopathologic analysis of biopsy

  5. number of patient with pain

    Time frame: 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)

  6. number of patient with endometrial acute infection

    Time frame: 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.

  7. number of patient with uterine perforation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: BEONE

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2015
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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