Deceased-donor uterine transplant for women with uterine-factor infertility
Official title: Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)
Run by Brigham and Women's Hospital · NCT04026893 · Data updated 2026-11-12
We will try a uterus transplant from a deceased donor to help women with uterine-factor infertility who can produce embryos and meet health and psychosocial requirements.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | October 2026 |
| Main results expected | December 2027 |
| Study ends | January 2028 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT04026893 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women of reproductive age with absolute uterine factor infertility, intact ovaries able to produce at least six euploid embryos, BMI ≤ 30, GFR ≥ 60, PRA ≤ 20%, and stable psychosocial support who pass medical and psychiatric screening are ideal candidates.
✕Probably not a fit
Women who cannot produce enough euploid embryos, have active substance use, unstable psychiatric or social situations, medical contraindications to major surgery or immunosuppression, or inability to adhere to follow-up and medication schedules are unlikely to qualify or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The program will identify reproductive-age women with absent or nonfunctional uteri but intact ovaries and good psychosocial support. Participants will undergo egg retrieval, IVF, and embryo cryopreservation, and those who produce at least six euploid embryos will be eligible for placement on a deceased-donor uterus waitlist. After transplant and an observation period (about six months) to confirm graft viability and normal menstrual function, embryo transfer will be attempted and pregnancies will be managed by high-risk obstetrics. Candidates will receive standard immunosuppression and close multidisciplinary follow-up throughout the process.
Why it matters
Potential benefit: If successful, this approach could allow women without a functional uterus to carry pregnancies and deliver using their own eggs.
How similar studies have gone: Uterine transplantation has led to pregnancies and live births at other centers—mostly from living donors—with deceased-donor programs less common but reported.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Evidence of AUFI diagnosed by BWH gynecologist * Ability to produce at least 6 euploid embryos for cryopreservation * BMI ≤ 30 * GFR 60 or greater in any patient including those with a single kidney * PRA 20% or less * Deemed stable and capable of undergoing transplant by the transplant team to include psychiatry, social work, and transplant coordinator and study doctors to assure compliance with treatment * Evidence to be compliant with follow-up and immunosuppression * 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 follow a strict medication dosing schedule post-transplant and adhere to required follow-up appointments. * Any co-morbidities which would increase surgical risk, risk of pregnancy or the risk of taking anti-rejection medications as determined by the Maternal Fetal Specialist and Transplant Surgeon. * Active infection: HIV, Hepatitis B, Hepatitis C * Inadequate blood vessels to support the transplanted uterus. * Prior extensive abdominal or pelvic surgery * Presence of pelvic kidney * History of abnormal PAP * HPV related vulvar, vaginal or cervical dysplasia * Evidence of genital condylomata * History of PID * One or more living biological children
Where it's running
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Brigham & Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Stefan G Tullius, MD — Brigham and Women's Hospital
- Study coordinator: Stefan G Tullius, MD
- Email: stullius@bwh.harvard.edu
- Phone: 617-732-6866
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using Platelet Rich Plasma to Improve Endometrial Thickness in Infertile Women
This study is testing if using Platelet Rich Plasma can help women with thin uterine lining improve their chances of getting pregnant through IVF.
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Uterine transplant for women with infertility due to absence of uterus
This study is testing if a uterine transplant from a donor can help women with no uterus due to infertility become pregnant and have a baby.
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In vitro maturation of human eggs for fertility treatment
This study is testing a new way to help women with fertility issues by maturing their eggs in the lab with fewer hormones to see if it makes treatment easier and safer.
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Uterus transplantation for women with uterine infertility
This study is testing if uterus transplants can help women who can't have children because they don't have a functioning uterus.
-
Uterus transplantation to help women with infertility
This study is testing if transplanting a uterus from a living donor can help women who don't have a uterus become pregnant and have healthy babies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.