Immunological Mechanisms of Rejection in Uterine Transplantation

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04615221

Acronym

MARNI

Enrollment

Registered

2020-11-04

Start date

2020-09-21

Completion date

2033-09-30

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant Rejection

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

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

Interventions

OTHERSpecimens

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
presence of new markers associated with transplant rejection	8 years

Secondary

Measure	Time frame
incidence of pregnancy on transplant immunology	8 years
microbiota in uterine transplant	8 years

Countries

France

Contacts

Primary ContactMarie Carbonnel, MD

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

Backup ContactElisabeth Hulier-Ammar

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026