Actively Recruiting
Uterine Transplant for Women With Absolute Uterine Factor Infertility (AUFI)
Led by John Goss · Updated on 2026-04-29
10
Participants Needed
1
Research Sites
443 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Absolute Uterine Factor Infertility (AUFI) is due to congenital or surgical absence of a uterus or the presence of a nonfunctional uterus. Until 2014, the only option for women affected by Absolute Uterine Factor Infertility (AUFI) was adoption or surrogate motherhood. Uterine transplant is a new form of transplant to treat AUFI. The technique of uterus transplant was developed in Sweden with the transplantation of the uterus from a living donor to a woman affected by AUFI. Approximately 80 uterine transplantations have been performed, more than 50 of which have occurred within the past 3 years. To date, 34 children have been born from mothers who have received a living donor uterine transplant. This is a prospective study to treat Absolute Uterine Factor Infertility (AUFI) through uterine transplantation utilizing a uterus from a living or deceased donor resulting in live birth. A total of 10 biologically female (XX Karyotype) subjects will receive a uterine transplant.
CONDITIONS
Official Title
Uterine Transplant for Women With Absolute Uterine Factor Infertility (AUFI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with Absolute Uterine Factor Infertility (AUFI) who have at least one functioning ovary
- Biologically female (XX karyotype) women aged 20 to 40 years
- No active human papillomavirus (HPV) or cervical dysplasia
- Negative tests for Gonorrhea, Chlamydia, Syphilis; no active bacterial vaginosis or candida infection
- HSV-2 negative or history of HSV-2 with no current symptoms
- Counseling received about fertility options including adoption and surrogacy
- Willingness to undergo in-vitro fertilization to obtain at least four viable embryos
- Good ovarian reserve and reproductive potential as evaluated by a fertility specialist
- Agreement to undergo hysterectomy if withdrawing while the transplanted uterus is in place
- Meets psychological recipient criteria
- Willingness to complete infant growth and development questionnaires
You will not qualify if you...
- Diabetes Mellitus Type I or II or elevated hemoglobin A1c
- Known hypersensitivity to Tacrolimus, Thymoglobulin, or Everolimus
- Diagnosis of hypertension or any medical condition contraindicating surgery or anesthesia
- History of solid organ or bone marrow transplant
- History of cancer
- Body mass index greater than 30
- Active infections including candida or bacterial vaginosis
- Positive for HIV, HBV, or HCV
- Anatomical malformations posing high surgical risk
- Unwilling or unable to comply with study requirements
- Unable to undergo in-vitro fertilization or not cleared for transplant
- Smoking within the last 6 months
- Alcohol or drug abuse within 12 months of screening
- Pre-existing conditions increasing medical risk, including Type 2 Mayer-Rokitansky-Kuster-Hauser syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Transplant Services Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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