Uterus Transplantation for Uterine Factor Infertility
Uterus Transplantation to Treat Infertility
Recruiting
Phase 2Phase 3Interventional Study
Uterine Factor Infertility
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 38
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for women who cannot become pregnant due to not having a uterus. Participants will receive a donated uterus to help them get pregnant and give birth to a child.
Are You a Good Fit for This Trial?
Rules you outInsulin-dependent diabetes mellitusActive hepatitis B infectionActive hepatitis C infectionToxoplasmosisMixed connective tissue diseasesThalassemiasSickle Cell disease
You may be able to join if
I am a genotypic female aged 18-38.
I have uterine factor infertility.
I have at least 4-8 frozen embryos at Johns Hopkins.
I am willing to have a uterus transplant.
I want to become pregnant and give birth.
I do not smoke.
I have no significant health conditions affecting surgery or pregnancy.
I agree to have the uterus removed after giving birth or after 5 years.
You may not be able to join if
I have a serious medical condition that could affect surgery.
I have had a positive HIV test.
I have active tuberculosis.
I have significant heart or vascular disease.
I have a history of medical non-compliance.
I am currently abusing drugs.
I have recent significant neurological deficits.
I have been advised against participating by a mental health professional.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 a…
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.
Trial Locations
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Eligibility Criteria
INCLUSION CRITERIA -
Recipient 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 cryopreser…
INCLUSION CRITERIA -
Recipient 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 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.
* 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 regime.
* 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-
Donor and Recipient 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.
* Toxoplasmosis.
* 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 donation.
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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