Uterine transplant for women with absolute uterine factor infertility
Uterine Transplant in Absolute Uterine Infertility (AUIF)
This program will try uterine transplants combined with IVF for women with absolute uterine factor infertility so they can attempt to carry and deliver their own children.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02741102 on ClinicalTrials.gov |
What this trial studies
At Brigham and Women's Hospital the team plans to screen about 30 candidates and enroll 10 people (five donors and five recipients) to begin a uterine transplant program. Recipients will undergo IVF to create embryos, receive a uterine transplant from a living donor, undergo embryo transfer, and, if pregnancy occurs, deliver; the transplanted uterus will later be removed. Candidates must meet strict medical and social criteria (for example, age 18–40, BMI under 30, normal kidney function, ability to produce at least six embryos, and stable support). Participants will receive close monitoring, including planned five-year follow-up after the uterus is explanted to track maternal and child outcomes and long-term safety.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–40 with absolute uterine factor infertility who can produce at least six embryos by IVF, have BMI <30, normal kidney function, stable social support, and can tolerate transplant immunosuppression and follow-up.
Not a fit: Patients who smoke or use illicit drugs, have active infections (HIV, TB, hepatitis B or C), cannot produce sufficient embryos, have conditions making pregnancy or immunosuppression too risky, or have extensive prior pelvic surgery are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could allow women with AUFI to carry and give birth to their own children.
How similar studies have performed: Live-donor uterine transplants in centers such as those in Sweden have produced live births, indicating the approach can work though it is still relatively new and not yet widespread.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Stefan G Tullius, M.D. — Brigham and Womens Hospital
- Study coordinator: Stefan G Tullius, M.D.
- Email: stullius@partners.org
- Phone: 617-732-6866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.