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

Part of paid clinical trials in Houston, Texas.

Sponsor
John Goss
Study ID
NCT05263076
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Uterine Transplant — OTHER
    Transplant of a uterus from a live or deceased donor.

Study Details

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.

Key Dates

Start date
Jun 3, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Uterine Transplant
    uterus transplantation from living or deceased donor.

Primary Outcome Measure

Number of participants that have successful procurement of a viable uterus for transplant. [ Time Frame: Day of organ procurement immediately post-operative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's HospitalHoustonTexas77030
Transplant Services Coordinator
[email protected]
832-822-1551
John Goss, M.D. (PRINCIPAL_INVESTIGATOR)
N. Thao Galvan, M.D., MPH (SUB_INVESTIGATOR)
Michael A Belfort, M.D., PhD (SUB_INVESTIGATOR)
Jennifer Dietrich, M.D., MSc (SUB_INVESTIGATOR)
Caitlin Sutton, M.D. (SUB_INVESTIGATOR)
Xiaoming Guan, M.D., PhD. (SUB_INVESTIGATOR)
Thierry Huisman, M.D. (SUB_INVESTIGATOR)
James Versalovic, M.D., PhD. (SUB_INVESTIGATOR)
Michael Coburn, M.D. (SUB_INVESTIGATOR)
Jan Sunde, M.D. (SUB_INVESTIGATOR)
Kristina Reber, M.D. (SUB_INVESTIGATOR)
Jean Raphael, M.D. (SUB_INVESTIGATOR)
Prakash Masand, M.D. (SUB_INVESTIGATOR)
Magdalena Sanz Cortes, M.D., PhD (SUB_INVESTIGATOR)
Dean Andropoulos, M.D. (SUB_INVESTIGATOR)
Larry Hollier Jr., M.D. (SUB_INVESTIGATOR)
Peter Jindra, PhD, D(ABHI) (SUB_INVESTIGATOR)
Theonia Boyd, M.D. (SUB_INVESTIGATOR)
Laura Detti, M.D. (SUB_INVESTIGATOR)
Julie Hakim, M.D. (SUB_INVESTIGATOR)
Ninad Patil, M.D. (SUB_INVESTIGATOR)
Nicole Cirino, M.D. (SUB_INVESTIGATOR)
Teni Davoudian, PhD (SUB_INVESTIGATOR)
Charlotte Kim, M.D. (SUB_INVESTIGATOR)
Roshni Parikh, MD (SUB_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
Texas Children's Hospital· Houston, TX

Related Studies