Immunological Mechanisms of Rejection in Uterine Transplantation

NCT04615221 | Recruiting

• 1 other identifier: 2019_0059
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• presence of new markers associated with transplant rejection

  8 years

Secondary Outcomes (2)

• incidence of pregnancy on transplant immunology

  8 years

• microbiota in uterine transplant

  8 years

Study Arms (3)

Graft recipient

OTHER

During each of the visits carried out with a cervical biopsy as part of the uterine transplant project, samples will be taken.

Other: Specimens

Living donor

OTHER

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

Witness

OTHER

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

Interventions

Specimens OTHER

Specimens (blood, biopsy, cervical smear, vaginal swab)

Graft recipient; Living donor; Witness

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92151, France

RECRUITING

Study Officials

• Jean-Marc Ayoubi, MD, PhD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Carbonnel, MD

CONTACT

+331 46 25 48 53; m.carbonnel@hopital-foch.com

Elisabeth Hulier-Ammar

CONTACT

+331 46 25 11 75; drci-promotion@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 4, 2020
• Study Start: September 21, 2020
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2033
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

FR (1)