250 Participants NeededMy employer runs this trial

Uterine Transplant for Infertility

SG
SW
Overseen ByShannon Weiss
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
Must be taking: Immunosuppressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the feasibility of performing uterus transplants from deceased donors for women unable to carry a child due to uterine issues. The process includes harvesting eggs, fertilizing them in a lab through in vitro fertilization, and freezing the embryos via embryo cryopreservation. Women who produce at least six healthy embryos may join a waiting list for a uterus transplant. Ideal candidates have intact ovaries, a stable home, and a supportive mental health environment, and face challenges in having children due to uterine problems. After a successful transplant, doctors will closely monitor both the transplant and the pregnancy. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in reproductive medicine.

What prior data suggests that this deceased donor uterine transplant is safe?

Studies have shown that uterus transplants from deceased donors can be a safe and viable option for women unable to have children due to uterine issues. Research indicates that about 74% of these transplants function well after one year. Additionally, around 75% of these surgeries succeed after three months, suggesting they are generally well-tolerated.

However, complications can occur, including bleeding, injury to nearby organs like the ureter, and discomfort. Despite these risks, many women with successful transplants have achieved live births. This demonstrates that while challenges exist, many women experience positive outcomes after the transplant.12345

Why are researchers excited about this trial?

Researchers are excited about the deceased uterine transplant for absolute uterine infertility because it offers a groundbreaking alternative to current options like surrogacy or adoption. This treatment involves transplanting a uterus from a deceased donor, which could allow women with uterine infertility to carry and give birth to their own biological children. Unlike traditional methods, this approach directly addresses the lack of a functional uterus, making it a potentially life-changing solution for many women. The prospect of restoring fertility in this way is a significant leap forward, sparking hope and excitement in the medical community.

What evidence suggests that this trial's treatments could be effective for uterine factor infertility?

Studies have shown that uterus transplants from deceased donors can help women unable to have children due to uterine problems. Research indicates that 70% of women receiving these transplants experience successful pregnancies, with many having at least one live birth. A review found that about 75% of the transplanted uteri remain healthy after a year. This treatment offers hope for those unable to carry a child because of uterine issues. Early evidence suggests that this procedure can enable pregnancy and childbirth for women who otherwise could not have children.12467

Who Is on the Research Team?

SG

Stefan G Tullius, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

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 of AUFI diagnosed by BWH gynecologist
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transplant Preparation

Participants undergo egg harvest, in vitro fertilization, and embryo cryopreservation

Varies

Waitlist and Transplant

Participants are placed on a waitlist for a deceased donor uterus transplant and undergo the transplant procedure

3 months

Post-Transplant Observation

Observation period to ensure normal menstrual cycle and graft viability

6 months

Embryo Implantation and Gestation

Embryo implantation followed by monitoring of gestation by high-risk pregnancy specialists

9 months

Post-Childbearing Follow-up

Monitoring outcomes for transplant recipients and live born infants for 30 days after removal of the transplanted uterus

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • Deceased Uterine Transplant
  • Egg Harvest
  • Embryo Cryopreservation
  • Immunosuppression Therapy
  • In Vitro Fertilization

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Deceased Donor Uterus TransplantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Citations

Deceased Donor Uterus Transplantation: A Narrative Review ...

A recent review of the first 5 years of UTx activity in the USA [15] reported a 1-year graft survival rate of 74% and 75% after LD and DD UTx, ...

Uterus Transplant in Women With Absolute Uterine-Factor ...

Findings In this series of 20 participants, uterus allograft was successful in 70% of recipients and was associated with at least 1 live birth ...

CLEVELAND CLINIC'S SIX YEAR REPORT

Our data demonstrate that deceased donor uterus transplantation is a viable surgical treatment for patients with uterine factor infertility.

Availability of deceased uterus donor: Is it a real case scenario ...

Thus, the aim of this study is to explore the feasibility of a deceased donor program in Catalonia by analyzing the potential number of uterine ...

Past, Present, and Future: A Review of Uterus Transplant - PMC

The next reported UTx was performed in Turkey in 2011 from a deceased donor [22]. For many years this case was considered a technical success ...

Uterus transplants linked to high live birth rate, longterm ...

Uterus transplants were associated with a high live birth rate among women with absolute uterine-factor infertility after success graft survival.

Deceased Donation Uterus Transplantation: A Review

Uterine graft survival for more than 3 months defines surgical success [24]. Of the 12 DD UTx performed, 9 (75%) achieved surgical success.