Immunological Mechanisms of Rejection in Uterine Transplantation (MARNI)

September 8, 2025 updated by: Hopital Foch
The objective of this study is to understand the mechanisms of rejection in uterine transplantation and to search for non-invasive markers of rejection. The biological samples necessary for our research have been or will be collected during procedures (biopsies, smears, vaginal swab, blood tests) carried out as part of the scheduled follow-up of patients. These will be samples whose collection is minimally or not invasive

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the context of uterine transplantation, non-invasive rejection markers will be sought by different approaches, including transcriptomics on a prospective cohort of patients with different types of samples: blood, smear and biopsy. A microbiota study will also be carried out. 3 groups will be studied: 1 group of 10 patients benefiting or having benefited from a uterine transplant, 1 second group made up of their 10 donors, 1 group of 10 control women

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient going to or having received a uterine transplant OR Patient going to or having donated a uterus for a recipient included in the study OR Premenopausal woman to undergo gynecological surgery under general anesthesia: for 4 of them it was a hysterectomy and they must be under 45 years old, the other 6 must be under 38 years old.

Exclusion Criteria (For witness):

  • Pregnancy in progress
  • Current infection
  • Cervical dysplasia
  • History of transplant or transfusion
  • Cancer or history of cancer
  • Menopause
  • Patient aged 38 or over for the 6 controls without hysterectomy, patient aged 45 or over for the 4 patients with hysterectomy.
  • Endometriosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Graft recipient
During each of the visits carried out with a cervical biopsy as part of the uterine transplant project, samples will be taken.
Other: Specimens
Specimens (blood, biopsy, cervical smear, vaginal swab)
Other: Living donor
The donors will benefit from a blood sample and a sample of the vaginal microbiota during the transplant under general anesthesia or after it during a consultation scheduled as part of the uterine transplant protocol.
Other: Specimens
Specimens (blood, biopsy, cervical smear, vaginal swab)
Other: Witness
10 non-menopausal control patients will each have a cervical biopsy (at different times of the cycle) and a smear, samples of the vaginal microbiota and a blood sample. Among the 10 controls, 4 patients will have to undergo a hysterectomy for which multiple staged biopsies and samples uterine microbiota will be produced.
Other: Specimens
Specimens (blood, biopsy, cervical smear, vaginal swab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence of new markers associated with transplant rejection
Time Frame: 8 years
8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of pregnancy on transplant immunology
Time Frame: 8 years
8 years
microbiota in uterine transplant
Time Frame: 8 years
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Jean-Marc Ayoubi, MD, PhD, Hôpital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2033

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2019_0059

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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