Uterine Transplant for Infertility
What You Need to Know Before You Apply
What is the purpose of this trial?
This study aims to investigate the treatment of absolute uterine infertility (AUI) due to congenital or surgical absence of a uterus or presence of a nonfunctioning uterus. The investigators will follow a model based on a Swedish study to enroll 20 women with functioning ovaries and successfully transplant the uterus from either a living or cadaveric donor, with the goal of live birth after transplantation.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity to certain medications like Tacrolimus, Thymoglobulin, or CellCept, you may not be eligible to participate.
Is uterine transplantation generally safe for humans?
The available research does not provide specific safety data on uterine transplantation, but it highlights the importance of adverse event reporting systems in organ and tissue transplantation to ensure safety and quality. These systems help identify trends and improve services, which could be applied to uterine transplantation as well.12345
How is uterine transplant treatment different from other infertility treatments?
Uterine transplant is unique because it involves surgically placing a healthy uterus from a donor into a woman who does not have a functioning uterus, allowing her the possibility to carry a pregnancy. Unlike other infertility treatments that may involve medication or assisted reproductive technologies, this procedure directly addresses the absence or dysfunction of the uterus itself.678910
What data supports the effectiveness of the treatment Uterine Transplant for Infertility?
Research shows that uterine transplantation (UTx) is evolving as a treatment for women with uterine-factor infertility, with early trials reporting successful procedures and the potential for achieving pregnancy. Studies in both humans and animal models indicate that UTx can lead to successful pregnancies and healthy births, suggesting its effectiveness in treating this type of infertility.610111213
Are You a Good Fit for This Trial?
This trial is for women aged 20-35 with absolute uterine infertility, who have functioning ovaries but no uterus due to congenital absence or surgical removal. Participants must be HPV negative, free from certain STIs, and able to fund assisted reproduction services. They should not have a BMI over 30, any substance abuse history in the past year, diabetes, uncontrolled hypertension, active infections or other medical conditions that increase risk.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Pre-transplant/Screening
Participants are screened for eligibility to participate in the trial
Transplant/Recovery
Participants undergo uterine transplantation and recovery from the procedure
Embryo transfer/Pregnancy
Embryo transfer is performed and participants are monitored for pregnancy
Delivery/Explant
Participants undergo delivery via cesarean section and potential explant of the uterus
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Uterine Transplant
Uterine Transplant is already approved in United States, European Union for the following indications:
- Absolute Uterine Factor Infertility (AUFI)
- Absolute Uterine Factor Infertility (AUFI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor Research Institute
Lead Sponsor