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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after transplant
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of successful live births after uterine transplant and IVF.
Side effects data
From 2018 Phase 4 trial • 2037 Patients • NCT0195081934%
Oedema peripheral
24%
Constipation
24%
Diarrhoea
24%
Hypertension
22%
Anaemia
22%
Urinary tract infection
19%
Hypophosphataemia
19%
Nausea
16%
Hyperkalaemia
15%
Hypokalaemia
14%
Hyperglycaemia
14%
Blood creatinine increased
13%
Diabetes mellitus
13%
Hyperlipidaemia
13%
Headache
13%
Hypomagnesaemia
13%
Proteinuria
12%
Vomiting
11%
Nasopharyngitis
11%
Hypocalcaemia
11%
Pyrexia
10%
Tremor
10%
Dyslipidaemia
10%
Hypercholesterolaemia
10%
Haematuria
10%
Insomnia
9%
Leukopenia
9%
Back pain
9%
Procedural pain
9%
Abdominal pain
8%
Metabolic acidosis
8%
Cough
8%
Upper respiratory tract infection
7%
Thrombocytopenia
7%
Dyspnoea
7%
Pain in extremity
6%
BK virus infection
6%
Complications of transplanted kidney
6%
Hypertriglyceridaemia
6%
Acne
6%
Arthralgia
6%
Dysuria
6%
Fatigue
6%
Hypotension
5%
Vitamin D deficiency
5%
Pneumonia
5%
Acute kidney injury
5%
Polycythaemia
5%
Tachycardia
5%
Hyperuricaemia
5%
Incision site pain
5%
Dizziness
5%
Anxiety
4%
Transplant rejection
4%
Abdominal pain upper
4%
Weight increased
4%
Hypercalcaemia
3%
Alopecia
3%
Lymphocele
2%
Kidney transplant rejection
2%
Gastroenteritis
2%
Pyelonephritis
2%
Sepsis
2%
Pulmonary embolism
2%
Cytomegalovirus infection
2%
Renal impairment
2%
Graft loss
2%
Deep vein thrombosis
2%
Leukocytosis
2%
Urosepsis
1%
Angina pectoris
1%
Cardiac failure congestive
1%
Impaired healing
1%
Pneumocystis jirovecii pneumonia
1%
Pyelonephritis acute
1%
Septic shock
1%
Delayed graft function
1%
Incisional hernia
1%
Transplant dysfunction
1%
Dehydration
1%
Osteonecrosis
1%
Squamous cell carcinoma
1%
Hydronephrosis
1%
Urinary incontinence
1%
Influenza
1%
Basal cell carcinoma
1%
Thrombotic microangiopathy
1%
Wound dehiscence
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Cardiac failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Everolimus Plus@Reduced CNI
MPA Plus Standard@CNI
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.
Find a Location
Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,401 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any possibility for me to participate in this examination?
"This study is accepting a maximum of 20 volunteers that meet the criteria of having infertility and being between the ages of 20 and 35."
Answered by AI
Does this medically-oriented experiment accept individuals aged 50 and up?
"In line with the study's guidelines, participants must be between 20 and 35 years old in order to qualify."
Answered by AI
Is there currently an opportunity for participation in this experiment?
"According to clinicaltrials.gov, this trial is not presently looking for new participants. It was initially posted on November 11th 2015 and last amended on March 7th 2022. Nevertheless, there are 247 other studies actively seeking individuals as we speak."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Ohio
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Baylor University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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