Study Of The Metabolic Parameters Of Uterine Muscle Cells

NCT ID: NCT03784157

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-13

Study Completion Date

2020-12-13

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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...)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier GARBIN, MD

Role: STUDY_DIRECTOR

University Hospital, Strasbourg, France

Locations

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Service de Gynécologie - CMCO

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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7222

Identifier Type: -

Identifier Source: org_study_id

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