Uterus Transplantation to Treat Infertility

NCT05646992 | Recruiting Phase 2 DMC

• 1 other identifier: IRB00166167
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will use uterus transplantation to treat uterine factor infertility, also known as the inability to bear children due to not having a uterus. The purpose of this study is to enable women seeking genetically-related children and the childbearing experience to experience pregnancy and birth a child. In this study, living donors will undergo surgery to give the donor's uterus to another woman. The woman who receives the transplant will take immunosuppression to keep the uterus and herself healthy. Because taking immunosuppressive medicine has side effects, uterus transplantation is intended to be temporary, lasting about 5 years. The goals of the study are successful pregnancy and the birth of one, and possibly two, healthy babies per transplant patient. The uterus is to be removed and immunosuppression stopped following the birth of a child. Offspring are delivered by Caesarian section, at which time the transplant may also be removed. Transplant candidates must have fertilized, frozen (cryopreserved) embryos at a Johns Hopkins facility before undergoing transplantation. Transplant candidates will be asked to identify candidates' potential uterus donor. Altruistic donors, or women who want to donate without knowing a potential recipient, may also participate. All potential donors will be screened to see if the donors are a good match for a recipient and are healthy enough to have the donation surgery. Study Duration:

• Uterus Donors: Screening through about 12 months following the transplant operation.
• Uterus Recipients: Recipients may have the uterus for about 5 years. After the transplant is removed, the study team will ask for yearly follow-ups for another 5 years.
• Children born from transplanted uteruses: The study team asks to follow offspring yearly through age 21 years.

Conditions

Uterine Factor Infertility

Keywords

Uterus/Transplantation; Uterus/Surgery; Vascularized Composite Allotransplantation (VCA); Immunosuppression; Mayer-Rokitansky-Küster-Hauser (MRKH); Allotransplantation; Humans; Female; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Successful delivery of viable baby

  Successful implantation of fertilized embryo which is then carried to term with the baby delivered by Cesarean section.

  Uterus transplantation to 5 years post uterus transplantation

Secondary Outcomes (11)

• Number of hazardous drinkers as assessed by Alcohol Use Disorders Identification Test-Concise (AUDIT-C)

  Pre-Transplantation Screening through 5 years post uterus explantation

• Stress as assessed by the Brief Coping Orientation to Problems Experienced (COPE)

  Pre-Transplantation Screening through 5 years post uterus explantation

• Resilience as assessed by the Connor Davidson Resilience Scale (CD-RISC)-10

  Pre-Transplantation Screening through 5 years post uterus explantation

• Relationship quality as assessed by the Dyadic Adjustment Scale (DAS) [if having child with a partner]

  Pre-Transplantation Screening through 5 years post uterus explantation

• Drug use as assessed by the Drug Abuse Screening Test (DAST) 10 Drug Use Questionnaire

  Pre-Transplantation Screening through 5 years post uterus explantation

Study Arms (1)

Uterus Transplant Recipient

EXPERIMENTAL

Uterus recipients, who are otherwise healthy, adult, genotypic females affected by uterine factor infertility, will undergo the surgically innovative uterus transplantation procedure combined with short-term use of conventional calcineurin inhibitor-based immunosuppression in to support a fetus to a viable delivery via Caesarian section.

Procedure: Uterine Allotransplantation; Drug: Tacrolimus; Drug: Imuran

Interventions

Uterine Allotransplantation PROCEDURE

Temporary allogenic uterus transplantation from a living donor with the goal of achieving pregnancy and delivering viable baby.

Uterus Transplant Recipient

Tacrolimus DRUG

Used as daily immunosuppression. Started at 3mg twice daily (PO) on post-operative Day 1, adjusted to achieve serum trough concentrations of 8-10ng/ml.

Also known as: FK506

Uterus Transplant Recipient

Imuran DRUG

Used as daily immunosuppresion. 100 mg for total body weight less than 75 kg and 150 mg for total body weight greater than or equal to 75 mgs

Also known as: Azathioprine

Uterus Transplant Recipient

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Genotypic female of any race, color, or ethnicity.
• Uterine factor infertility.
• Aged 18-38 years at time of egg retrieval.
• Strong desire to undergo uterus transplant in order to become pregnant and give birth to a child.
• Embryo cryopreservation with embryos located at Johns Hopkins:
• Has a minimum of 4-8 cryopreserved normal embryos following Preimplantation Genetic Screening (PGS-screening).
• OR o Is willing to undergo egg retrieval, in vitro fertilization, and PGS-screening to cryopreserve a minimum of 4-8 normal embryos.
• Willingness to undergo embryo implantation after uterus transplantation to achieve pregnancy.
• In the opinion of the study team, makes a reasonable effort to identify and refer her own potential uterus donor to the study team.
• Completes the protocol informed consent form.
• Non-smoker, defined by having never smoked or having quit \>6 consecutive months prior to screening.

You may not qualify if:

• Negative serum pregnancy test.
• Blood type compatible with donor.
• Negative crossmatch with donor.
• Patient agrees to comply with the protocol and states a dedication to the treatment regime.
• Agrees to uterus explanation following birth of a child and or 5 years without successful pregnancy.
• Genotypic female with an intact uterus.
• Medical history includes known successful pregnancy (e.g., gravid uterus).
• Aged 25 - 65 years.
• Consents to uterus donation and required pre-donation screening.
• For females of child-bearing potential: Negative serum pregnancy test.
• Blood type compatible with recipient.
• Negative crossmatch with recipient.
• USA citizen or equivalent.
• No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
• BMI ≤35

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Interventions

Tacrolimus; Azathioprine

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Richard J Redett, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Littleton, CRNP, MSN

CONTACT

410-955-6875; jlittl38@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): February 28, 2033
• Study Completion (Estimated): February 28, 2043
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (1)