Status:
ACTIVE_NOT_RECRUITING
The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial
Lead Sponsor:
University of Pennsylvania
Conditions:
Mayer Rokitansky Kuster Hauser Syndrome
Uterine Agenesis
Eligibility:
FEMALE
21-40 years
Phase:
NA
Brief Summary
Options for childbearing are limited for the thousands of women in the United States who suffer from absolute uterine factor infertility. Uterine transplantation is an emerging treatment that provides...
Detailed Description
BACKGROUND The inability to conceive children can be one of the most devastating and traumatic situations to arise in the life of an individual or couple. While assisted reproductive technologies have...
Eligibility Criteria
Inclusion
- Uterine Transplant Recipient Participant
- XX-bearing individual diagnosed with Uterine Factor Infertility (UFI) a
- Age 21-40
- Lives in Philadelphia region for the duration of the trial
- Received counseling regarding alternatives to uterine transplant such as adoption or surrogacy
- Intact ovaries
- Vaginal length \>6 cm (average vaginal length established with dilators)
- Body mass index \<35 kg/m2
- Fluent in the English Language
- If cervix present/previously present, human papillomavirus (HPV)) negative or received vaccination for HPV
- Willing to comply with screening, protocol and all required procedures
- Has adequate social support
- Has undergone controlled ovarian hyperstimulation, egg retrieval, in vitro fertilization, and embryo freezing and has frozen embryos of sufficient embryo quality/quantity (≥2 high quality blastocysts); (Required for Transplant Phase, not Screening or Evaluation Phases)
- Uterine Transplant Recipient Participant
Exclusion
- Previous multiple major abdominal/pelvic surgery
- Severe endometriosis
- History of hypertension, diabetes mellitus, thrombophilia or other clotting or bleeding disorders, significant heart, liver, kidney or central nervous system disease
- History of prior malignancy except for cervical cancer in stage 1a or 1b (must be in remission for 3 years)
- History of significant psychiatric illness
- Allergy, hypersensitivity, or intolerance of expected immunosuppressive agents (i.e. Thymoglobulin®, tacrolimus, etc.)
- Allergy, hypersensitivity, or intolerance of heparin or aspirin
- Presence of active documented systemic infection or recent systemic infection within the past 3 months
- Seropositivity for HIV, HBV core antibody or antigen, HCV
- Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
- Chemical and/or alcohol dependency or abuse
- Psychosocial problems (including alcoholism, drug abuse, documented behavioral disorders)
- Renal abnormalities, specifically single kidney or pelvic kidneys (imaging confirmation of 2 normal kidneys is required for MRKH subjects)
- Contraindications to pregnancy
- Unwilling to receive a transfusion of blood or blood products
- Living Donor Participant Inclusion Criteria:
- Age 30-50
- Has definitively completed childbearing
- Live birth to miscarriage ratio ≥1
- Body mass index \<35 kg/m2
- Normal uterine anatomy
- Normal pap test and Human papillomavirus (HPV) negative
- Negative infection screen (HIV, HepB, HepC, Syphilis, gonorrhea, chlamydia)
- Received counseling regarding alternatives to uterus donation such as adoption and gestational surrogacy
- Fluent in the English Language
- Willing to comply with screening, protocol and all required procedures
- Has adequate social support
- Compatible blood type with recipient
- Negative flow cytometric crossmatch with recipient
- Has current health insurance
- Able to stay in the Philadelphia region for 3 weeks following uterus donation
- Living Donor Participant
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03307356
Start Date
January 10 2018
End Date
July 1 2029
Last Update
August 5 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104