Immunological Mechanisms of Rejection in Uterine Transplantation

Transplant Rejection Clinical Trial

— MARNI  

Official title:

Immunological Mechanisms of Rejection in Uterine Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615221
• Other study ID #: 2019_0059
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: September 2028

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: Marie Carbonnel, MD
• Phone: +331 46 25 48 53
• Email: m.carbonnel[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2028
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Transplant Rejection

Intervention

Other:
• Specimens
Specimens (blood, biopsy, cervical smear, vaginal swab)

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of new markers associated with transplant rejection		8 years
Secondary	incidence of pregnancy on transplant immunology		8 years
Secondary	microbiota in uterine transplant		8 years