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Study Of The Metabolic Parameters Of Uterine Muscle Cells

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT03784157
Collaborator
(none)
20
Enrollment
1
Location
24
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of the main reservations lies in the ischemic properties of the uterine graft between the sampling time and the grafting time.

Investigators propose to carry out a prospective monocentric study at the University Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the time of ischemia of the uterine muscle The objective is to carry out a preparatory study on healthy uteri to study the ischemic properties of uterine muscle from living markers: study of mitochondrial respiration and free radical production on uterine muscle samples If the markers are reliable, they would then be used to measure the ischemia of whole uteri collected at the end of the multi-organ retrieval process from donors in a state of brain death and stored in tissue survival media.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Study Of The Metabolic Parameters Of Uterine Muscle Cells In Cold Ischemia From Hysterectomies Programmed For Benign
    Actual Study Start Date :
    Dec 13, 2018
    Actual Primary Completion Date :
    Dec 13, 2020
    Actual Study Completion Date :
    Dec 13, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Ischemia [1 hour after sampling]

      Study physiologically the time of ischemia of the uterine muscle 1 hour after sampling

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Inclusion criteria:
      • Adult patient

    • Patient benefiting from the routine management of a programmed hysterectomy by vaginal, laparoscopic or laparotomy for benign pathologies (fibroma, adenomyosis, genital prolapse,...) within the CMCO

    • Patient consenting to the use of cells from her uterus for incineration for research purposes

    • Patient giving her consent for the use of her medical data for the purposes of this research.

    • Patient agreeing to participate in the study

    Exclusion criteria:
      • Patient refusing to participate in the study

    • Patient under the protection of justice

    • Patient under guardianship or curatorship

    • Suspicion of gynaecological malignant pathology

    • Pregnant or breastfeeding woman

    • Impossibility to give the subject informed information (difficulties in understanding the subject...)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Gynécologie - CMCO Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Study Director: Olivier GARBIN, MD, University Hospital, Strasbourg, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT03784157
    Other Study ID Numbers:
    • 7222
    First Posted:
    Dec 21, 2018
    Last Update Posted:
    Feb 16, 2021
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Hysterotomy
    UTERINE MUSCLE CELLS
    ISCHEMIA
    COLD ISCHEMIA
    Additional relevant MeSH terms:
    Ischemia

    Study Results

    No Results Posted as of Feb 16, 2021