20 Participants Needed

Uterine Transplant for Infertility

Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Baylor Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

I am a woman aged between 20 and 35.
I am HPV negative or vaccinated, with no recent HPV history.
A subject who is negative for Gonorrhea, Chlamydia, and Syphilis
See 7 more

Exclusion Criteria

Subject who has alcohol or drug abuse within 12 months of screening
Subject who is seropositive for HIV, HBV, HCV
Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator
See 11 more

Timeline for a Trial Participant

Pre-transplant/Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplant/Recovery

Participants undergo uterine transplantation and recovery from the procedure

6-12 weeks

Embryo transfer/Pregnancy

Embryo transfer is performed and participants are monitored for pregnancy

Up to 2 years

Delivery/Explant

Participants undergo delivery via cesarean section and potential explant of the uterus

Varies based on pregnancy outcome

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years post-transplant

What Are the Treatments Tested in This Trial?

Interventions

  • Uterine Transplant
Trial Overview The study tests uterine transplants from living or deceased donors in women with absolute uterine infertility aiming for a successful pregnancy and live birth. It follows a model based on previous Swedish research and involves subsequent in-vitro fertilization procedures after transplantation.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Uterine TransplantExperimental Treatment1 Intervention
Women will undergo uterine transplantation after IVF. Donor uterus will be from either a living donor or cadaveric.

Uterine Transplant is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Uterus Transplantation for:
  • Absolute Uterine Factor Infertility (AUFI)
🇪🇺
Approved in European Union as Uterus Transplantation for:
  • Absolute Uterine Factor Infertility (AUFI)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+

Published Research Related to This Trial

In a study of 10 uterus transplant procedures (5 from live donors and 5 from deceased donors), the graft survival rate was 70% at one year, indicating a promising mid-term viability for this treatment of uterine-factor infertility.
The study resulted in three live births, demonstrating the potential effectiveness of both live and deceased donor uterus transplants, while also highlighting challenges such as a 63% incidence of vaginal anastomotic stenosis and cases of severe acute rejection.
Human Uterus Transplantation from Living and Deceased Donors: The Interim Results of the First 10 Cases of the Czech Trial.Fronek, J., Kristek, J., Chlupac, J., et al.[2021]
The first clinical uterus transplantation trial showed that after 6 months, 7 out of 9 transplanted uteri remained viable and allowed for regular menstrual cycles, indicating the procedure's potential effectiveness for treating absolute uterine-factor infertility.
No immediate complications were reported during surgery, and mild rejection episodes in four patients were successfully managed with corticosteroids, demonstrating the safety of the low-dose immunosuppression protocol used.
First clinical uterus transplantation trial: a six-month report.Brännström, M., Johannesson, L., Dahm-Kähler, P., et al.[2022]
Uterine transplantation (UTx) is a promising treatment for women with uterine factor infertility, aiming to replace a non-functioning or absent uterus.
Since the first human UTx attempt 10 years ago, extensive research has focused on improving surgical techniques, understanding ischaemia-reperfusion injury, managing immunosuppression, and enhancing fertility outcomes.
Uterine transplantation: one human case followed by a decade of experimental research in animal models.Hanafy, A., Diaz-Garcia, C., Olausson, M., et al.[2022]

Citations

Human Uterus Transplantation from Living and Deceased Donors: The Interim Results of the First 10 Cases of the Czech Trial. [2021]
First clinical uterus transplantation trial: a six-month report. [2022]
Uterine transplantation: one human case followed by a decade of experimental research in animal models. [2022]
Uterus transplantation - donor and recipient work-up. [2021]
Achieving an early pregnancy following allogeneic uterine transplantation in a rabbit model. [2021]
Adverse Events Reporting Systems in Cells, Organs, and Tissues Donation and Transplantation: Scoping Review. [2023]
A UK scheme for reporting serious adverse events and reactions associated with ocular tissue transplantation. [2016]
Risk management in IVF. [2007]
[Assisted reproduction vigilance]. [2006]
Increased pregnancy complications following frozen-thawed embryo transfer during an artificial cycle. [2020]
11.Czech Republicpubmed.ncbi.nlm.nih.gov
Uterine transplantation in an era of successful childbirths from living and deceased donor uteri: Current challenges. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Registry of the International Society of Uterus Transplantation: First Report. [2023]
Uterus allotransplantation in cynomolgus macaque: a preliminary experience with non-human primate models. [2014]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security