Immunological Mechanisms of Rejection in Uterine Transplantation

Not Applicable

Recruiting

• Conditions: Transplant Rejection
• Interventions: Other: Specimens

• Registration Number: NCT04615221
• Lead Sponsor: Hopital Foch

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

Study Timeline

• Study Start: 2020-09-21
• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Witness	Specimens	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.
Living donor	Specimens	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.
Graft recipient	Specimens	During each of the visits carried out with a cervical biopsy as part of the uterine transplant project, samples will be taken.

Primary Outcome Measures

Name	Time	Method
presence of new markers associated with transplant rejection	8 years

Secondary Outcome Measures

Name	Time	Method
incidence of pregnancy on transplant immunology	8 years
microbiota in uterine transplant	8 years

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France