Uterus transplantation from live and deceased donors
Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study
This study is testing if uterus transplants from both living and deceased donors can help women who can't have children due to a missing uterus.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague) |
| Trial ID | NCT03277430 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the effectiveness of uterus transplantation (UTx) as a treatment for women with congenital or acquired absence of the uterus, known as absolute uterine factor infertility. The study will involve 20 UTx procedures, split into two groups: 10 from live donors and 10 from deceased donors after brain death. Participants will undergo in vitro fertilization, embryo cryopreservation, uterus retrieval, and subsequent transplantation, followed by monitoring for pregnancy and childbirth outcomes. The goal is to expand on previous successful cases and potentially introduce UTx into clinical practice for women desiring to have children.
Who should consider this trial
Good fit: Ideal candidates include women aged 18-40 with congenital or acquired absence of the uterus who desire to have children.
Not a fit: Patients over the age of 40 or those with serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable women with uterine infertility to conceive and carry their own children.
How similar studies have performed: Previous studies, particularly in Sweden, have shown favorable outcomes for uterus transplantation, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for UTx recipient: * 18 - 40 years of age * good general health * congenital or acquired uterus absence * desire for a child Exclusion Criteria for UTx recipient: * age over 40 * serious comorbidity Inclusion Criteria for a live uterus donor: * female * 18 - 60 years of age * maximum 4 child births * maximum 1 Cesarian section * good general health Exclusion Criteria for a live uterus donor: * age over 60 * hypertension with organ damage * diabetes mellitus * other serious comorbidity Inclusion Criteria for a deceased brain-dead uterus donor: * female * age under 60 * no previous hysterectomy * no previous uterus malignancy
Where this trial is running
Prague
- Institute for Clinical and Experimental Medicine — Prague, Czechia (Recruiting)
Study contacts
- Principal investigator: Jiri Fronek, Assoc Prof — Transplant Surgery Department, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
- Study coordinator: Jiri Fronek, Assoc Prof
- Email: jifr@ikem.cz
- Phone: +420 26 136 4105
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.