What this study is
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.
What's being tested
- Uterine Allotransplantation
Intervention · PROCEDURE
Temporary allogenic uterus transplantation from a living donor with the goal of achieving pregnancy and delivering viable baby.
- Tacrolimus
Intervention · 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.
- Imuran
Intervention · 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
Study details
- Official title
- OPRTUNTI: Offering Potential for Reproduction Through Transplantation of Uterus iN the Treatment of Infertility
- Sponsor
- Johns Hopkins University
- Conditions
- Uterine Factor Infertility
- Enrolling
- 40 people
- Starts
- 2023-03-01
- Est. completion
- 2043-02-28
- Design
- Open-label, single group, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 38 YearsSex FEMALEHealthy volunteers AcceptedRecipient
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.
- 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.
You can't join if
- 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.
- Conditions that, in the opinion of the study team, may expose the recipient to unacceptable risks under immunosuppressive treatment.
Donor
You may qualify if
- 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.
You can't join if
- 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.
- Conditions that, in the opinion of the study team, may expose the recipient to unacceptable risks under immunosuppressive treatment.
Donor and Recipient
You may qualify if
- 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.
You can't join if
- 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.
- 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.
- Conditions that, in the opinion of the study team, may expose the recipient to unacceptable risks under immunosuppressive treatment.
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Study locations (1)
1 openJohns Hopkins University School of Medicine
Baltimore, Maryland, United States
- Jane Littleton, AG-ACNP, FNP · Contact410-614-5551jlittl38@jhmi.edu
- Richard J. Redett, MD · Principal investigator
- Andrew J. Satin, MD · Principal investigator
- Amanda Nickles Fader, MD · Sub-investigator
- James H. Segars, MD · Sub-investigator
Recruiting
Study team
Sponsor
Johns Hopkins University
Study ID IRB00166167
Principal investigator
Richard J Redett, MD
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.