Uterine Transplant for Female Infertility
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to explore the possibility of starting a uterine transplant program to help women with Absolute Uterine Factor Infertility (AUFI) become pregnant. It involves several steps, including IVF (in vitro fertilization), uterine transplantation (also known as Uterus Transplantation or UTx), and embryo transfer, to help women achieve a full-term pregnancy. Women with AUFI who have stable home environments, supportive partners, and can produce at least six healthy embryos are ideal candidates for this trial.
As a Phase 2, Phase 3 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group and is in the final step before FDA approval. Participants have the opportunity to contribute to groundbreaking advancements in fertility treatment.
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, you must be able to comply with required treatments, which might include taking new medications.
What prior data suggests that uterine transplantation is safe for women with AUFI?
Research has shown that uterine transplants can be safe and effective for women unable to have children due to Absolute Uterine Factor Infertility (AUFI). Studies have found that about 19% of women who receive a transplant experience complications, such as early birth or breathing difficulties. Despite these risks, uterine transplants often result in successful pregnancies and births when the transplanted uterus functions well.
Recipients of a uterine transplant must take medications to prevent rejection of the new uterus. These medications, including Thymoglobulin, Prednisone, and Tacrolimus, are essential but may cause side effects. Over time, Mycophenolate Mofetil (MMF) is typically replaced with Azathioprine to reduce the risk of birth defects.
Overall, while risks exist, the procedure has been successful for many women. Potential participants should discuss these risks and benefits with their healthcare providers.12345Why are researchers excited about this trial's treatment for AUFI?
Unlike traditional treatments for absolute uterine infertility, such as surrogacy or adoption, uterine transplant offers the possibility for women to carry and deliver their own child. This treatment is unique because it involves transplanting a healthy uterus from a donor, enabling natural conception through in vitro fertilization. Researchers are excited about this approach because it provides an opportunity for women with AUFI to experience pregnancy and childbirth firsthand, which is not possible with existing options. Additionally, the use of pre-screened embryos and careful management of anti-rejection medications aim to minimize risks and improve the chances of successful, full-term pregnancies.
What evidence suggests that uterine transplant might be an effective treatment for AUFI?
Research has shown that uterine transplant offers a promising option for women unable to have children due to Absolute Uterine Factor Infertility (AUFI). In this trial, women with AUFI will undergo uterine transplantation, followed by in vitro fertilization to achieve pregnancy. Studies have found that this procedure can be performed successfully and often results in high rates of live births when the transplanted uterus functions well. Recent reviews highlight improvements in the survival of the transplanted uterus, the frequency of pregnancies, and the health of newborns, indicating significant progress in the procedure. Uterine transplantation currently remains the only method for women with AUFI to become pregnant and give birth. However, some complications have been reported, so participants must carefully consider both the potential benefits and risks.13567
Who Is on the Research Team?
Stefan G Tullius, M.D.
Principal Investigator
Brigham and Womens Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
In Vitro Fertilization
In Vitro Fertilization is started with the goal of obtaining 6 normal embryos for implantation
Uterine Transplantation
The uterus of a suitable live donor is transplanted into the recipient
Embryo Transfer and Pregnancy
Up to 6 embryo transfer cycles are attempted, followed by monitoring during pregnancy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including monitoring for complications and quality of life assessments
What Are the Treatments Tested in This Trial?
Interventions
- Uterine Transplant
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Women with AUFI must meet criteria for uterine transplant. In vitro fertilization to obtain 6 (screened) healthy embryos for cryo-preservation precedes uterine transplant from an appropriate donor The recipient will be required to take potent anti rejection medications including Thymoglobulin, Prednisone, Tacrolimus, Mycophenolate Mofetil (MMF) , later substituted with Azathioprine to avoid birth defects. One year later, up to 6 attempts using 1 screened embryo at a time will be tried to achieve pregnancy. During pregnancy, the high risk pregnancy and transplant teams will follow the recipient. The goal is a full term baby and delivery will be by Caesarian section. A second pregnancy may be attempted. Afterward, the uterus will be explanted.
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?
Brigham and Women's Hospital
Lead Sponsor
Citations
Uterus Transplant in Women With Absolute Uterine-Factor ...
Uterus transplant was technically feasible and was associated with a high live birth rate following successful graft survival.
Uterine Transplantation for Absolute Uterine Factor Infertility
Recent reviews highlight progressive improvements in graft survival, pregnancy rates, and neonatal outcomes, as well as significant advancements ...
Uterine Transplant for Women With Absolute Uterine Factor ...
This is a prospective study to treat Absolute Uterine Factor Infertility (AUFI) through uterine transplantation utilizing a uterus from a living or deceased ...
Uterine Transplantation for Absolute Uterine Factor Infertility
Uterine transplantation is currently the only treatment that allows women with absolute uterine factor infertility (AUFI) to gestate and give birth.
Uterus Transplantation for Absolute Uterine Factor Infertility
Factor Infertility: A Traditional Review of Safety and Efficacy Outcomes in the First 65 Recipients of. Uterus Transplantation. Cureus. Jan 18 2021; 13(1): ...
The reproductive potential of uterus transplantation - PMC - NIH
Absolute uterine factor infertility (AUFI) is a form of infertility whereby conception and/or maintenance of pregnancy is impossible as a result of uterine ...
Uterine Transplantation for Absolute Uterine Factor Infertility
Uterus transplantation (UTx) has emerged as a promising reproductive option for women with absolute uterine factor infertility, ...
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