Boston, MANCT04026893Now EnrollingIRB Ready

Infertility of Uterine Origin Clinical Trial in Boston, MA

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

Sponsored by Brigham and Women's Hospital

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Expert Care in Boston

Access infertility of uterine origin specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related infertility of uterine origin treatment provided free

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Check if you qualify for this infertility of uterine origin clinical trial in Boston, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA 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 Boston site if eligible
  4. 4Begin participation

About This Infertility of Uterine Origin Study in Boston

Our study will explore the feasibility of initiating a deceased donor uterine transplant program in addition to the existing living donor IRB at BWH. Using the template established by teams around the world, we will identify emotionally and socially stable females of reproductive age with intact ovaries who are unable to gestate a child due to congenital or acquired uterine factor infertility. After careful screening, participants will undergo egg harvest, in vitro fertilization, and embryo cryopreservation using standard methods. Women who successfully complete the fertilization of at least six euploid embryos will be eligible to be placed on the waitlist for a deceased donor uterus transplant. After a successful transplant and a period of observation to ensure normal menstrual cycle and graft viability (anticipate six months), embryo implantation will be undertaken. Following an embryo transfer, gestation will be carefully monitored by our high-risk pregnancy specialists. Medical research interventions include the surgical implantation of a uterus utilizing techniques by teams that have applied this approach successfully, close post-transplant follow up including immunosuppression therapy tailored to established standards during pregnancy minimizing fetal risks, and careful management of pregnancy. After childbearing is complete (at most two gestations), the donor uterus will be removed either during Cesarean or during an elective procedure. In addition, open ended interviews and surveys will be conducted to elicit ethical and psychosocial concerns arising from the experience of subjects and their families, health care providers, and the wider community. The investigator's intent is to monitor outcomes for transplant recipients as well as the live born infants for 30 days after removal of the transplanted uterus. It is estimated that the time from screening to a potential live birth will be a minimum of 22 months, but likely between 24 - 36 months depending on organ availability.

Sponsor: Brigham and Women's Hospital

Who Can Participate

Inclusion Criteria

Evidence of AUFI diagnosed by BWH gynecologist
Ability to produce at least 6 euploid embryos for cryopreservation
GFR 60 or greater in any patient including those with a single kidney
PRA 20% or less
Deemed stable and capable of undergoing transplant by the transplant team to include psychiatry, social work, and transplant coordinator and study doctors to assure compliance with treatment
Evidence to be compliant with follow-up and immunosuppression
Partner willing to undergo psychological evaluation and receive immunizations as recommended
Stable home environment to support a child

Exclusion Criteria

Active smoking, alcohol use or use of illicit drugs
Inability to follow a strict medication dosing schedule post-transplant and adhere to required follow-up appointments.
Any co-morbidities which would increase surgical risk, risk of pregnancy or the risk of taking anti-rejection medications as determined by the Maternal Fetal Specialist and Transplant Surgeon.
Active infection: HIV, Hepatitis B, Hepatitis C
Inadequate blood vessels to support the transplanted uterus.
Prior extensive abdominal or pelvic surgery
Presence of pelvic kidney
History of abnormal PAP
HPV related vulvar, vaginal or cervical dysplasia
Evidence of genital condylomata
History of PID
One or more living biological children

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 Boston?

Yes, this clinical trial (NCT04026893) has an active research site in Boston, MA 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.

Infertility of Uterine Origin Treatment Options in Boston, MA

If you're searching for infertility of uterine origin treatment options in Boston, MA, this clinical trial (NCT04026893) 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 Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced infertility of uterine origin 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 infertility of uterine origin clinical trials near you to find additional studies recruiting in your area.

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