Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 38Years
FEMALE
Healthy Volunteers
NCT05646992

Uterus Transplantation to Treat Infertility

Led by Johns Hopkins University · Updated on 2025-08-14

40

Participants Needed

1

Research Sites

1043 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Uterus Transplantation to Treat Infertility

Who Can Participate

Age: 18Years - 38Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Recipient must be a genotypic female aged 18-38 years with uterine factor infertility
  • Strong desire to undergo uterus transplant to become pregnant and give birth
  • Must have 4-8 cryopreserved normal embryos at Johns Hopkins or be willing to undergo IVF and embryo freezing
  • Willing to try embryo implantation after uterus transplantation
  • Must make reasonable effort to identify and refer a potential uterus donor
  • Must complete informed consent
  • Must be a non-smoker (never smoked or quit >6 months prior to screening)
  • No medical condition that could affect immunosuppression, surgery, or pregnancy
  • Negative pregnancy test
  • Blood type compatible with donor and negative crossmatch
  • Agree to uterus removal after birth or 5 years without pregnancy
  • Donors must be genotypic females aged 25-65 with intact uterus and history of successful pregnancy
  • Donors must consent to donation and screening, have negative pregnancy test if of childbearing potential
  • Donors and recipients must be USA citizens or equivalent, have BMI ≤35 (higher BMI may be allowed by study team), be negative for HIV and malignancy for past 5 years, and have no psycho-social problems
Not Eligible

You will not qualify if you...

  • Positive for insulin-dependent diabetes mellitus, untreated sepsis, HIV, active tuberculosis, active Hepatitis B or C, viral encephalitis, toxoplasmosis
  • Recent or current IV drug abuse within 3 months
  • Significant cardiac or vascular disease
  • High levels of panel-reactive HLA antibodies (≥50%) in recipients
  • Conditions affecting surgery success or increasing post-op risks such as inherited clotting disorders, connective tissue diseases, severe neurologic deficits
  • Unsuitable psychiatric or psychological evaluation
  • History of medical non-compliance
  • Donor only: previous uterine injury including Cesarean section, history of abdominal radiation, other disqualifying medical conditions
  • Recipient only: conditions causing unacceptable risks under immunosuppressive treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

J

Jane Littleton, CRNP, MSN

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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