Immunological Mechanisms of Rejection in Uterine Transplantation

Study Overview
=================
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

Official Title
-----------------
Immunological Mechanisms of Rejection in Uterine Transplantation

Conditions
-----------------
Transplant Rejection

Intervention / Treatment
-----------------
* Other: Specimens


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Graft recipient<br>During each of the visits carried out with a cervical biopsy as part of the uterine transplant project, samples will be taken. | Other: Specimens<br>* Specimens (blood, biopsy, cervical smear, vaginal swab)<br>|
| Other: Living donor<br>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<br>* Specimens (blood, biopsy, cervical smear, vaginal swab)<br>|
| Other: Witness<br>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<br>* Specimens (blood, biopsy, cervical smear, vaginal swab)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of new markers associated with transplant rejection |  | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pregnancy on transplant immunology |  | 8 years | 
| microbiota in uterine transplant |  | 8 years |