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OpenTrials
Completed

NCT Number: NCT03784157

Study Of The Metabolic Parameters Of Uterine Muscle Cells

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de Gynécologie - CMCO

Strasbourg, 67091, France

Who can participate

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

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...)

Treatment and study plan

Primary outcomes

  1. Ischemia

    Time frame: 1 hour after sampling

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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Study Of The Metabolic Parameters Of Uterine Muscle Cells In Cold Ischemia From Hysterectomies Programmed For Benign

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2018
Registry last updated
Feb 16, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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