Understanding rejection in uterine transplantation
Immunological Mechanisms of Rejection in Uterine Transplantation
NA · Hopital Foch · NCT04615221
This study is trying to understand why some uterine transplants are rejected by the body and find easier ways to check for rejection in patients who have received or donated a uterus.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Hopital Foch (other) |
| Locations | 1 site (Suresnes) |
| Trial ID | NCT04615221 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the immunological mechanisms behind rejection in uterine transplantation and identify non-invasive markers for rejection. Researchers will collect biological samples, including blood, biopsies, and vaginal swabs, from a cohort of patients who have received or donated a uterus, as well as control participants. The study will utilize transcriptomics and microbiota analysis to explore differences among the groups. By focusing on minimally invasive sample collection, the study seeks to enhance patient comfort while gathering essential data.
Who should consider this trial
Good fit: Ideal candidates include women who are undergoing or have received a uterine transplant, their donors, and premenopausal women undergoing gynecological surgery.
Not a fit: Patients who are pregnant, have current infections, or have a history of cancer or other specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved monitoring and management of uterine transplant rejection, enhancing patient outcomes.
How similar studies have performed: While the approach of identifying non-invasive rejection markers is innovative, similar studies in other transplant areas have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Suresnes
- Hopital Foch — Suresnes, France (RECRUITING)
Study contacts
- Principal investigator: Jean-Marc Ayoubi, MD, PhD — Hopital Foch
- Study coordinator: Marie Carbonnel, MD
- Email: m.carbonnel@hopital-foch.com
- Phone: +331 46 25 48 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Transplant Rejection