Uterine Transplant for Women With Absolute Uterine Factor Infertility (AUFI)

NCT05263076 | Recruiting DMC

• 1 other identifier: H-49601
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Absence of Uterus; Infertility of Uterine Origin; Mayer Rokitansky Kuster Hauser Syndrome

Keywords

Uterine Transplant; AUFI; Absolute Uterine Factor Infertility; Infertility; MRKH

Outcome Measures

Primary Outcomes (5)

• Number of participants that have successful procurement of a viable uterus for transplant.

  A viable uterus is a uterine allograft that is fully procured and is suitable for transplantation into the recipient. This is measured at the time of procurement by visible inspection to ensure the vascular structures (uterine artery and vein) are not injured and the vaginal cuff is intact.

  Day of organ procurement immediately post-operative

• Number of participants that have a score of II or less on the Clavian-Dindo Scale.

  Each patient will be reviewed and any complications scored using the Clavian Dindo Scale.

  30 days post-operative

• Successful transplantation of a human uterus with achievement of menstrual cycles

  As determined by 1. Achievement of menstrual cycles at 3 months post-operative, and 2. Graft viability measured by assessing blood flow via ultrasound and using cervical biopsies to look for ischemia or allograft rejection.

  3 months post-operative

• Successful establishment of a pregnancy via in vitro fertilization

  Visibility of a gestational sac on US at 6 weeks

  6 weeks post IVF

• Successful live birth

  Viable infant born ≥ 23 weeks gestation

  at birth

Study Arms (1)

Uterine Transplant

EXPERIMENTAL

uterus transplantation from living or deceased donor.

Other: Uterine Transplant

Interventions

Uterine Transplant OTHER

Transplant of a uterus from a live or deceased donor.

Uterine Transplant

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are diagnosed with Absolute Uterine Factor Infertility (AUFI) and who have at least one functioning ovary.
• Women of childbearing age (20-40 years old) who are biologically female (XX karyotype).
• Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
• Subjects will have negative testing for Gonorrhea Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (Subjects with previously treated STDs will be included if the infection is no longer present and has no impact. If a subject develops an STD/infection pre-operatively, she will be treated and monitored for a period of 3 months until she is no longer affected. She will then become eligible for transplant. If a subject develops an STD/infection after transplant/during pregnancy she will be treated appropriately. Prior to the embryo transfer the patient will be tested and treated if necessary. Any patient with an active STD/infection will be ineligible for any elective procedure until she is tested and treated appropriately.)
• Subjects who are HSV-2 negative or who have a history of HSV-2 with no current symptoms. Subjects may require preventative maintenance per study doctor discretion.
• Subjects have received counseling regarding all fertility options and alternatives to uterine transplant such as adoption or surrogate pregnancy.
• Subjects are willing to undergo in-vitro fertilization to obtain the necessary 4 viable embryos required for eligibility for transplant if they have not already banked 4 viable embryos.
• Subjects have been evaluated by a fertility specialist and determined to have good ovarian reserve and reproductive potential.
• Subjects must agree that in the event of withdrawal from the study while the transplanted uterus is in place, unless she is enrolled in an equivalent uterine transplant program, she will be required to undergo a hysterectomy for her own safety.
• Subject meets psychological recipient criteria.
• Subject must be willing to complete questionnaires about their infant's growth and development and return them to the study team.

You may not qualify if:

• Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test.
• Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or Everolimus.
• Subject with a diagnosis of hypertension, or any other significant medical condition that makes this procedure unsafe or is a contraindication to surgery or anesthesia.
• Subject who has a history of solid organ or bone marrow transplant, per investigator's discretion.
• Subject who has a history of cancer, per investigator's discretion.
• Subject with a body mass index \>30.
• Subject with an active infection including candida and/or bacterial vaginosis.
• Subject who is seropositive for HIV, HBV, HCV.
• Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator.
• Subject unwilling or unable to comply with study requirements.
• Subject unable to undergo in-vitro fertilization or not cleared for transplant.
• Subject who has smoked within the last 6 months.
• Subject who has alcohol or drug abuse within 12 months of screening.
• Subject with any pre-existing clinical or medical conditions that would put the subject at an increased risk. Of note, for Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome, the investigators will favor Type 1 variants as Type 2 is associated with skeletal/spinal and renal anomalies, making them higher risk candidates.
• Women must be between 25-65 years of age. If a subject is less than 40 years old she must be certain that she does not wish to carry more children, and she will attest to this decision.

Sponsors & Collaborators

• John Goss: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Mullerian aplasia; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• John Goss, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Transplant Services Coordinator

CONTACT

832-822-1551; uterustransplant@texaschildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief, Division of Abdominal Transplantation, Department of Surgery

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: March 2, 2022
• Study Start: June 3, 2022
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)