NCT02741102 · Brigham and Women's Hospital
Uterine Transplant in Absolute Uterine Infertility (AUIF)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Exclusion criteria
- RECIPIENT:Inclusion Criteria
- 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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations