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Procedure
Uterine Transplant for Infertility
N/A
Waitlist Available
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women diagnosed with Absolute Uterine Infertility (AUI) and intact native ovaries
Must have the ability to fund, either through third party coverage or through their own personal financing, any expenses associated with assisted reproduction services provided to them
Must not have
Subject with a body mass index >30
Subject unable to undergo in-vitro fertilization or not cleared for transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after transplant
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating if transplanting a uterus from a donor can allow a woman with absolute uterine infertility to have a child.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include complications related to surgery such as infection or bleeding; rejection of the transplanted uterus requiring immunosuppressive drugs which can lead to increased infection risk; and possible adverse reactions to fertility treatments involved.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman with a diagnosis of Absolute Uterine Infertility and I still have my ovaries.
Select...
I can pay for fertility treatments myself or through insurance.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My BMI is over 30.
Select...
I cannot have in-vitro fertilization or am not approved for a transplant.
Select...
I have had a solid organ or bone marrow transplant.
Select...
I currently have an active infection.
Select...
I have been diagnosed with Type I or II diabetes.
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I have had cancer within the last five years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years after transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after transplant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of successful live births after uterine transplant and IVF.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
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Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,405 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had herpes in the past, but currently, you don't have any symptoms. However, you may need to take medication to prevent it from recurring during the study, as determined by the study doctor.You are willing to undergo in-vitro fertilization and medically cleared for in-vitro fertilization.I am a woman aged between 20 and 35.I am HPV negative or vaccinated, with no recent HPV history.I am a woman with a diagnosis of Absolute Uterine Infertility and I still have my ovaries.I can pay for fertility treatments myself or through insurance.My BMI is over 30.I have been informed about infertility options like adoption or surrogacy.I cannot have in-vitro fertilization or am not approved for a transplant.I have been counseled on options like adoption or surrogacy instead of uterine transplant.I am a woman diagnosed with AUI but still have my ovaries.You must be able to fund, either through third party coverage or through other their own personal financing, any expenses associated with assisted reproduction services provided to them.I am a woman aged between 20 and 35.I have had a solid organ or bone marrow transplant.I currently have an active infection.I have been diagnosed with Type I or II diabetes.I have a history of HSV-2 but no current symptoms.I have had cancer within the last five years.
Research Study Groups:
This trial has the following groups:- Group 1: Uterine Transplant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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