Study Of The Metabolic Parameters Of Uterine Muscle Cells

Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784157
• Other study ID #: 7222
• Status: Completed
• Start date: December 13, 2018
• Est. completion date: December 13, 2020

Study information

• Verified date: December 2018
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 13, 2020
• Est. primary completion date: December 13, 2020
• Gender: Female
• Age group: 18 Years and older

Eligibility

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...)

Related Conditions & MeSH terms

• Ischemia

Locations

Country	Name	City	State
France	Service de Gynécologie - CMCO	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia	Study physiologically the time of ischemia of the uterine muscle 1 hour after sampling	1 hour after sampling