Baltimore, MDNCT05646992Now EnrollingIRB Ready

Uterine Factor Infertility Clinical Trial in Baltimore, MD

Access cutting-edge uterine factor infertility treatment through this clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Johns Hopkins University

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related uterine factor infertility treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Uterine Factor Infertility Study in Baltimore

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.

Sponsor: Johns Hopkins University

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT05646992) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Uterine Factor Infertility Treatment Options in Baltimore, MD

If you're searching for uterine factor infertility treatment options in Baltimore, MD, this clinical trial (NCT05646992) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced uterine factor infertility specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all uterine factor infertility clinical trials near you to find additional studies recruiting in your area.

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