Uterus Transplantation to Treat Infertility (OPRTUNTI)

  • End date
    Feb 28, 2043
  • participants needed
  • sponsor
    Johns Hopkins University
Updated on 29 August 2023
Accepts healthy volunteers


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.


This is a prospective clinical cohort study to establish temporary allogenic uterus transplantation as a feasible and effective reconstructive strategy for the treatment of uterine factor infertility.

Suitable candidates will proceed through as many as nine study stages:

  • Stage 1: Telephone Screening Interview
  • Stage 2: Blood Work Screening
  • Stage 3: In Vitro Fertilization (IVF) & Embryo Cryopreservation
  • Stage 4: Full Screening
  • Stage 5: Transplantation
  • Stage 6: Embryo Transfer
  • Stage 7: Pregnancy to Childbirth
  • Stage 8: Uterus Explantation
  • Stage 9: Longitudinal Follow-Up

Potential participants will first be screened by phone for general eligibility, motivations for transplantation, and probable identification of a living donor. Potential donors will be interviewed by an Independent Living Donor Advocate to determine eligibility. Suitable candidates and candidates' potential living donors will then undergo blood work screening to determine if it's an acceptable pairing for donation and transplantation. Next, if the recipient does not already have embryos banked at a Johns Hopkins Hospital facility, she will participate in IVF and embryo cryopreservation per standard of care protocols. After a sufficient number of fertilized embryos have been successfully stored, the participant and her living donor will undergo full study screening. Donor/recipient pairs deemed suitable for transplantation based on screening results will be scheduled for and undergo transplant surgery. Post-uterus donation, the donor will be followed according to post-hysterectomy surgery patient care protocols. Post transplantation, the recipient will continue under the care of the study team as a transplant patient as well as under the care of gynecologists, obstetricians, and maternal fetal medicine experts. Depending on the transplant recipient's post-operative course, embryo transfer may be attempted as early as 2 months post-transplant. Should the patient become pregnant, obstetrics will follow the participant's and her fetus' progress. Whether or not the recipient successfully carries a pregnancy or births a child, uterus explantation is an anticipated endpoint of this protocol. Patients will be counseled that participants may have the transplant to birth up to two offspring or for about five years, whichever comes first, after which removal of the uterus should be considered.

Study data on uterus transplant recipients will be collected for 5 years post-transplantation under this protocol, or for the entire time the participant has the graft, plus five years post-explantation. All attempts will be made to collect data on the offspring born as a result of this protocol through the offspring's 21st birthday.

Condition Uterine Factor Infertility
Treatment Tacrolimus, Azathioprine, Imuran, Uterine Allotransplantation
Clinical Study IdentifierNCT05646992
SponsorJohns Hopkins University
Last Modified on29 August 2023


Yes No Not Sure

Inclusion Criteria

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
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
No co-existing medical condition which, in the opinion of the study team, could affect
the immunosuppression protocol, surgical procedure, or ability to be pregnant or bear
a child. (See Donor and Recipient Exclusion Criteria below. If the condition is
amenable to treatment, the study team must agree that said condition should not
significantly enhance the surgical risks of uterus transplantation.)
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
Agrees to uterus explanation following birth of a child and or 5 years without
successful pregnancy
Donor Inclusion Criteria
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
Donor and Recipient Inclusion Criteria
USA citizen or equivalent
No co-existing psycho-social problems (i.e., alcoholism, drug abuse)
BMI ≤35
o A higher BMI may be accepted at the discretion of the study team
Negative for HIV at transplant
Negative for malignancy for past 5 years

Exclusion Criteria

Positive for any of the following conditions
Insulin-dependent diabetes mellitus
Untreated sepsis
HIV (active or seropositive)
Active tuberculosis
Active Hepatitis B infection
Active Hepatitis C infection
Viral encephalitis
Current/recent (within 3 months of donation/screening consent) IV drug abuse
Significant cardiac disease
Significant vascular disease o
Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte
Antigens (HLA) antibodies
Conditions that may impact the success of the surgical procedure or increase the risk
of postoperative complications including inherited coagulopathies like Hemophilia
Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias
Sickle Cell disease, etc
Mixed connective tissue diseases and collagen diseases that can result in poor wound
healing after surgery
Severe neurologic deficits
Patients considered unsuitable per the consulted Psychiatric/Psychologic appraisal
A history of medical non-compliance
Donor Only Exclusion Criteria
Previous injury to the uterus including giving birth by Cesarean section
History of radiation therapy to the abdominal area
Other medical conditions, as determined by the study physicians, that would preclude
Recipient Only Exclusion Criteria
• Conditions that, in the opinion of the study team, may expose the recipient to
unacceptable risks under immunosuppressive treatment
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