Immunological Mechanisms of Rejection in Uterine Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Specimens.
- Who it may be relevant to
- Registry conditions: Transplant Rejection. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Specimens
Specimens (blood, biopsy, cervical smear, vaginal swab)
Primary outcome measures
- presence of new markers associated with transplant rejection [Time frame: 8 years]
Secondary outcome measures (2)
- incidence of pregnancy on transplant immunology [Time frame: 8 years]
- microbiota in uterine transplant [Time frame: 8 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Hopital Foch — Suresnes
Identifiers
NCT: NCT04615221 · 2019_0059