Study Of The Metabolic Parameters Of Uterine Muscle Cells

NCT03784157 | Completed

• 1 other identifier: 7222
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia

Keywords

Hysterotomy; UTERINE MUSCLE CELLS; ISCHEMIA; COLD ISCHEMIA

Outcome Measures

Primary Outcomes (1)

• Ischemia

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

  1 hour after sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient benefiting from the routine management of a programmed hysterectomy by vaginal, laparoscopic or laparotomy for benign pathologies

You may qualify if:

• \- 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

You may not qualify if:

• \- 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...)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Gynécologie - CMCO

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier GARBIN, MD

  University Hospital, Strasbourg, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 21, 2018
• Study Start: December 13, 2018
• Primary Completion: December 13, 2020
• Study Completion: December 13, 2020
• Last Updated: February 16, 2021

Record last verified: 2018-12

Locations

FR (1)