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New treatment option for Uterine Factor Infertility
Official title Uterus Transplantation to Treat Infertility
ClinicalTrials.gov ID: NCT05646992
What this study is testing
What is Tacrolimus?
Tacrolimus is an investigational medicine, given as an once-daily, being studied as a potential treatment for uterine factor infertility.
Also referred to as FK506.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 38, women only. Healthy volunteers may be eligible.
You may be able to join if
- Recipient
- 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.
You likely can't join if
- below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks...
- 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:
See the full eligibility criteria
- Recipient
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 38 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.