Uterus transplantation from a living donor
Feasibility Study of Uterus Transplantation Procedure From a Live Donor Obtaining the Graft by Laparoscopy
This study is testing if women who can't have babies due to a missing uterus can successfully receive a uterus from a living donor to help them get pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04314869 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the feasibility of uterus transplantation from a living donor for women suffering from absolute uterine factor, such as those with Rokitansky Kuster Hauser Syndrome. The procedure will be performed laparoscopically to enhance safety and minimize invasiveness. Five pairs of uterine donors and recipients will be included, with the goal of achieving pregnancy through embryo transfer six months post-transplant. The study will also assess the outcomes of two gestations if sufficient embryos are available.
Who should consider this trial
Good fit: Ideal candidates are women under 40 years old with sterility due to absolute uterine factor and who have produced quality embryos through IVF.
Not a fit: Patients with medical conditions that contraindicate complex surgical procedures or pregnancy, as well as those with severe anatomical alterations, will not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide a pathway for women with absolute uterine factor to experience genetic and gestational motherhood.
How similar studies have performed: While uterus transplantation is a relatively novel approach, previous studies have shown promising outcomes in similar cases, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Recipient: * Patient with sterility for absolute uterine factor (malformation or previous surgery for benign processes). * Age \<40 years. * Absence of pathology that contraindicates a complex surgical process, immunosuppression or gestation. * Positive results to the IVF cycle prior to the surgery, obtaining quality embryos. * Acceptance to participate in the study signing the informed consent. Exclusion Criteria Recipient: * Medical or surgical pathology that contraindicates a complex pelvic surgical procedure. * Medical conditions that contraindicate, may aggravate or complicate the immunosuppressor treatment, such as neoplastic or preneoplasic diseases, chronic infectious diseases, autoimmune diseases, renal or liver failure. * Medical or surgical pathology that contraindicates pregnancy. * Anatomic alterations or vascular pathology that might difficult the vascular anastomosis: severe endometriosis, pelvic kidney, severe adherence syndrome or others. * Uncontrolled psychopathology. Inclusion Criteria donor: * Age \<65 years. * First- or second-degree relatives. * Completed reproductive desire. * History of previous pregnancies and births. * Absence of associated pathology that contraindicates prolonged and complex laparoscopic surgery (pneumopathies, heart disease, morbid obesity, ...). * Acceptance to participate in the study signing the informed consent Exclusion Criteria donor: * Potential future pregnancy desire. * Surgery for the treatment of gender identity disorder. * Infections: HIV or risk group, HBV-DNA and / or HBsAg positive, positive HCV, active bacterial sepsis, infections with multi-resistant bacteria, active tuberculosis or incomplete treatment of the same, Chagas disease, untreated active viral infections. * Active malignant cancer of any location, except skin basal cell carcinoma. Treated cancer without current evidence of illness but with a follow-up of less than 5 years. * Benign pelvic pathology: uterine fibroids, uterine malformations, severe endometriosis, severe adherence syndrome. * Vascular pathology: malformations, atheromatosis, hypertensive or diabetic vasculopathy, connective tissue disease with vascular involvement. * Premalignant pelvic pathology: pre-invasive cervical and/or vaginal, endometrial hyperplasia. * BRCA mutation carriers or genes related to Lynch syndrome. * History of implantation failure or multiple abortions of unknown cause. * Contraindications for the surgical procedure of donation through laparoscopy: diabetes mellitus, liver disease, nephropathy, heart disease, pneumopathy, morbid obesity or high-risk cardiovascular factors.
Where this trial is running
Barcelona
- Hospital Clinic — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Francisco Carmona, MD, PhD — Hospital Clinic of Barcelona
- Study coordinator: Mariona Rius, MD
- Email: marius@clinic.cat
- Phone: 932275400
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.