Immunological Mechanisms of Rejection in Uterine Transplantation (MARNI)

Hopital Foch

Status: Enrolling

Conditions: Transplant Rejection

Treatments: Other: Specimens

Study type: Interventional

Funder types: Other

Identifiers

NCT04615221

2019_0059

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Graft recipient

Other group

Description:

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

Treatment:

Other: Specimens

Living donor

Other group

Description:

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.

Treatment:

Other: Specimens

Witness

Other group

Description:

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.

Treatment:

Other: Specimens