BridgeMD
New treatment option for Female Infertility
Official title Uterine Transplant in Absolute Uterine Infertility (AUIF)
ClinicalTrials.gov ID: NCT02741102
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- Uterine Transplant Inclusion/
You likely can't join if
- 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
See the full eligibility criteria
- Uterine Transplant Inclusion/
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.