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RecruitingNCT05263076Updated Apr 29, 2026

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

An interventional study of Uterine Transplant in Mayer Rokitansky Kuster Hauser Syndrome, Absence of Uterus and Infertility of Uterine Origin, sponsored by John Goss. Recruiting at 1 site in United States. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by John Goss · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 5 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years to 65 Years
Sex
Female
01

Study 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.

Read the detailed description

BACKGROUND: The feasibility of uterine transplant has been studied for more than a decade. The clinical concept and the technical aspects were first tested and proven in non-primates and then in primate experiments. In 2013, the first human trial started at the University of Gothenburg in Sweden. In 2014, the first live birth from a woman who had received a uterine transplant was announced (1). This first live birth was then followed by additional births. Uterine transplant may provide an additional option for women with Absolute Uterine Factor Infertility (AUFI).

STUDY DESIGN: This trial will be conducted at Texas Children's Hospital - Pavilion for Women. Texas Children's Hospital was established in 1954. Today it has one of the nation's top pediatric transplant programs. The transplant center has performed more than 2000 solid organ transplants including liver, kidney, heart and lung transplants. This is a non-randomized, interventional study with the goal of achieving pregnancy and live birth of a child following uterine transplantation using either a live or deceased uterus donor. The investigators plan to perform 10 uterine transplants in this study.

The evaluation for receiving a uterine transplant will include consults with specialists and a variety of procedures. The consultations, tests and procedures will evaluate if the recipient is physically, emotionally, and mentally prepared to participate. After the evaluations are complete, the principal investigator and coordinator will present the findings to the rest of the uterine team. The team will decide if the subject is a candidate for moving forward to the IVF part of the screening process. After successful completion of egg retrieval and fertilization, the embryos will be banked. Only those study subjects that have four or more high quality embryos will be the criteria to be listed as uterine transplant recipients. Preimplantation Genetic Testing for Aneuploidy will be done. Once the subject has undergone uterine transplantation, she will be monitored for infection, rejection and other complications.

Once it has been determined that the study subject is ready for the embryo transfer, the subject will undergo a process to prepare the uterus to receive the embryo (embryo transfer). The endometrium will be stimulated to grow with estrogen until a desired thickness of the lining has been obtained. A second hormone, progesterone, will be given by injection daily until the endometrial lining is receptive to transfer of the embryo. On the day of the transfer, the embryo will be thawed and then transferred into the uterus by means of a sterile catheter system under ultrasound guidance to determine the proper placement of the embryo into the uterus. The study subject will be awake during this process. Twelve days later, blood tests will be performed to detect the pregnancy hormone, HCG. The levels of the pregnancy hormone and the estrogen and progesterone levels will be closely monitored. At eight weeks gestation, the study subject will undergo an ultrasound evaluation to see if there is viable pregnancy. The study subject will then be closely monitored by the fertility specialist until about 11 weeks, and then by a Maternal-Fetal Medicine (MFM) specialist.

All deliveries will be performed via cesarean section. Following delivery, the subject will have the opportunity to discuss with the transplant and Ob/Gyn team the possibility of a second pregnancy or explant of the uterus. If a second pregnancy is anticipated the subject must be deemed medically stable to undergo the embryo transfer and a second-high risk pregnancy. The subject and team will determine the timeline for a second pregnancy if the subject so chooses. If the subject chooses to undergo a second pregnancy, she will be followed by a Maternal Fetal Medicine specialist and delivery via repeat cesarean delivery. After delivery of the first pregnancy, a decision about a second pregnancy or an explant will not be made until at least 60 days post-delivery to allow time to evaluate the health of the newborn as well as the candidacy of the subject for a possible second pregnancy (if desired). In the case of a second pregnancy, the plan will be to perform a hysterectomy of the uterine allograft at the time of cesarean delivery of the second child.

The transplanted uterus will be from either living or deceased donors. TXTC wants to be certain that the living donor's decision to donate is made freely, and with all of the information needed to consider donation. For that reason, TXTC has an agreement with the Living Bank that will serve as an independent third party advocating for the rights and needs of the donor through the evaluation and donation process. UNOS is the only source for deceased donor organs. Locally, TXTC works with the Lifegift OPO to procure organs for transplant.

02

Conditions studied

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

Keywords

  • Uterine Transplant
  • AUFI
  • Absolute Uterine Factor Infertility
  • Infertility
  • MRKH
03

In context

Mullerian aplasia

20 studies on the registry are indexed under Mullerian aplasia; 11 are open to participants now.

This study's planned enrollment of 10 is below the median of 20 across 13 interventional studies indexed under Mullerian aplasia.

Browse Mullerian aplasia studies →

Lead sponsor

This is the only study on the registry with John Goss as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

RECIPIENT INCLUSION CRITERIA

  1. Women who are diagnosed with Absolute Uterine Factor Infertility (AUFI) and who have at least one functioning ovary.
  2. Women of childbearing age (20-40 years old) who are biologically female (XX karyotype).
  3. Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
  4. 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.)
  5. 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.
  6. Subjects have received counseling regarding all fertility options and alternatives to uterine transplant such as adoption or surrogate pregnancy.
  7. 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.
  8. Subjects have been evaluated by a fertility specialist and determined to have good ovarian reserve and .
  9. 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.
  10. Subject meets psychological recipient criteria.
  11. Subject must be willing to complete questionnaires about their infant's growth and development and return them to the study team.

RECIPIENT EXCLUSION CRITERIA

  1. Subject with Diabetes Mellitus Type I and II by medical history or elevated blood test.
  2. Subject has known to Tacrolimus, Thymoglobulin or Everolimus.
  3. Subject with a diagnosis of hypertension, or any other significant medical condition that makes this procedure unsafe or is a to surgery or anesthesia.
  4. Subject who has a history of solid organ or bone marrow transplant, per investigator's discretion.
  5. Subject who has a history of cancer, per investigator's discretion.
  6. Subject with a >30.
  7. Subject with an active infection including candida and/or bacterial vaginosis.
  8. Subject who is seropositive for , , .
  9. Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator.
  10. Subject unwilling or unable to comply with study requirements.
  11. Subject unable to undergo in-vitro fertilization or not cleared for transplant.
  12. Subject who has smoked within the last 6 months.
  13. Subject who has alcohol or drug abuse within 12 months of screening.
  14. 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.

DONOR INCLUSION CRITERIA

  1. 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.
  2. Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
  3. 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. Any patient with an active STD/infection will be ineligible for any elective procedure until she is tested and treated appropriately.)
  4. Subjects who are HSV-2 negative, or have a history of HSV-2 but with no current symptoms. Subjects may require preventative maintenance per study doctor discretion.
  5. Subjects will have a normal uterus on sonogram and CT.
  6. Subjects will have normal psychological donor criteria (if living).
  7. Subjects will have had at least one prior full term live birth.

DONOR EXCLUSION CRITERIA

  1. Donor over the age of 65.
  2. Body mass index >30.
  3. Subject with an active infection including candida and/or bacterial vaginosis.
  4. Subject who is seropositive for HIV, HBV, HCV
  5. Subject who has had cancer in the last five years.
  6. Subject with any pre-existing clinical or medical condition that would place the subject at an increased risk or would be a contraindication to surgery or anesthesia.
  7. Subject who has smoked within the last 6 months.
  8. Subject who has alcohol or drug abuse within 12 months of screening.
  9. Subject unwilling or unable to comply with study requirements.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Uterine Transplant

    uterus transplantation from living or deceased donor.

    Other: Uterine Transplant

Interventions

  • OtherUterine Transplant

    Transplant of a uterus from a live or deceased donor.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day of organ procurement immediately post-operative

  2. 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.

    Time frame: 30 days post-operative

  3. 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.

    Time frame: 3 months post-operative

  4. Successful establishment of a pregnancy via in vitro fertilization

    Visibility of a gestational sac on US at 6 weeks

    Time frame: 6 weeks post IVF

  5. Successful live birth

    Viable infant born ≥ 23 weeks gestation

    Time frame: at birth

07

Study locations

1 of 1 sites recruiting
  • Texas Children's Hospital
    Houston, Texas 77030, United States
    Recruiting
    • Transplant Services Coordinator · Contactuterustransplant@texaschildrens.org · 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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2022 (actual). Primary completion is estimated for Dec 2030, 102 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2022
First posted
Mar 2, 2022
StartActual
Jun 3, 2022
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05263076
Lead sponsor
John Goss
Responsible party
John Goss (Professor and Chief, Division of Abdominal Transplantation, Department of Surgery, Baylor College of Medicine) — Sponsor-investigator
First posted
Mar 2, 2022
Start date
Jun 3, 2022
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Apr 29, 2026

Study contacts

Transplant Services Coordinator
Contact
uterustransplant@texaschildrens.org
832-822-1551
John Goss, M.D.
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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