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NCT Number: NCT04615221

Immunological Mechanisms of Rejection in Uterine Transplantation

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

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92151, France

Location status: Recruiting

Location contact

Marie Carbonnel

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specimens

Other

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

Primary outcomes

  1. presence of new markers associated with transplant rejection

    Time frame: 8 years

Secondary outcomes

  1. incidence of pregnancy on transplant immunology

    Time frame: 8 years

  2. microbiota in uterine transplant

    Time frame: 8 years

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Hulier-Ammar

CONTACT

[email protected]

+331 46 25 11 75

Marie Carbonnel, MD

CONTACT

[email protected]

+331 46 25 48 53

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: MARNI

Important dates

Study start
2020
Primary completion
2027
Study completion
2033
First posted
Nov 4, 2020
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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