Status:
UNKNOWN
Uterus Transplantation Procedure From a Live Donor
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Rokitansky Kuster Hauser Syndrome
Sterility, Female
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
Absolut uterine factor, meaning the absence of uterus, represents a cause for sterility without the possibility of a present treatment. The uterine factor affects millions of women and may be due to c...
Detailed Description
To obtain by laparoscopy a viable uterus for transplantation from a living donor is feasible. The laparoscopic procedure increases safety and provides the benefits of minimally invasive surgery to the...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04314869
Start Date
May 23 2020
End Date
December 1 2025
Last Update
November 10 2020
Active Locations (1)
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1
Hospital Clinic
Barcelona, Spain, 08036