Immunological Mechanisms of Rejection in Uterine Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2033-09-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Transplant Rejection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Graft recipient

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

Group Type OTHER

Specimens

Intervention Type OTHER

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

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.

Group Type OTHER

Specimens

Intervention Type OTHER

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

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.

Group Type OTHER

Specimens

Intervention Type OTHER

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

Interventions

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Specimens

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No