Uterine Transplant for Absolute Uterine Infertility
Uterine Transplant in Absolute Uterine Infertility (AUIF)
Recruiting
Phase 2Phase 3Interventional Study
Female Infertility
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 40
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
3 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for women aged 18 to 40 who cannot carry a pregnancy due to uterine issues. Participants will undergo a uterine transplant, which includes IVF and follow-up after delivery.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 40 years old.
I have been diagnosed with Absolute Uterine Factor Infertility.
I can produce at least 6 normal embryos through IVF.
I have a body mass index (BMI) less than 30.
I have normal kidney function.
I can comply with treatment requirements.
I have a stable partner and social support.
I have a stable home environment for a child.
You may not be able to join if
I smoke, drink alcohol, or use drugs.
I cannot comply with treatment requirements.
I have a condition that makes pregnancy risky.
I have an active infection like HIV or Hepatitis.
I have had extensive abdominal or pelvic surgery.
I have a history of abnormal PAP smears.
I have a history of pelvic inflammatory disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Deli…
This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of follow-up is planned.
Trial Locations
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Eligibility Criteria
Uterine Transplant Inclusion/Exclusion Criteria
RECIPIENT:Inclusion Criteria
* Age 18-40
* Clinical evidence of AUFI (Absolute Uterine Factor Infertility)
* Able to produce at least 6 normal embryos by IVF for future use
* Reasonable weight with BMI (Body Mass Index) less than 30.
* Normal kidney …
Uterine Transplant Inclusion/Exclusion Criteria
RECIPIENT:Inclusion Criteria
* Age 18-40
* Clinical evidence of AUFI (Absolute Uterine Factor Infertility)
* Able to produce at least 6 normal embryos by IVF for future use
* Reasonable weight with BMI (Body Mass Index) less than 30.
* Normal kidney function
* Able to undergo transplant and be compliant with treatment
* Has stable partner and social supports
* Partner willing to undergo psychological evaluation and receive immunizations as recommended
* Stable home environment to support a child
Exclusion Criteria :
* Active smoking, alcohol use or use of illicit drugs
* Inability to comply with required treatment (taking pills, having biopsies, frequent appointments )
* Having a condition that would make pregnancy or taking anti rejection medicines too risky.
* Active infection: Human Immunodeficiency Virus (HIV) , Tuberculosis, Hepatitis B, Hepatitis C
* History of extensive abdominal or pelvic surgery
* History of abnormal Papanicolaou test (PAP smear) or genital warts
* History of pelvic inflammatory disease
DONOR:Inclusion criteria
* Age over 40 up to age 60
* Has completed having a family
* Previous pregnancies were carried to term (no miscarriages)
* Able to take a birth control pill containing estrogen
* Weight reasonable with BMI (Body Mass Index) of 30 or less
* Good social supports
Exclusion Criteria:
* Active smoking, alcohol use or use of illicit drugs
* Psychiatric illness
* Cervical or endometrial polyps (growths) or tumors in the uterus muscle
* History of more than 1 Caesarean section
* History of abnormal PAP smear or genital warts
* Internal scarring from extensive abdominal or pelvic surgery
* Hypertension, Coronary artery disease, Chronic Obstructive Lung disease (emphysema) and Diabetes
* Active cancer or incompletely treated cancer
* Active infection including Human Immunodeficiency Disease (HIV) , Tuberculosis, Hepatitis B or Hepatitis C
* Significant history of either blood clots or bleeding tendencies
* Evidence of coercion or exchange of money or goods for donating the organ
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