Infertility of Uterine OriginNCT04026893
Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)
A study testing Uterine Transplant from Deceased Donor in people with Infertility of Uterine Origin, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Our study will explore the feasibility of initiating a deceased donor uterine transplant program in addition to the existing living donor IRB at BWH. Using the template established by teams around the world, we will identify emotionally and socially stable females of reproductive age with intact ovaries who are unable… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility of Uterine Origin
- What is being tested?
- Uterine Transplant from Deceased Donor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Stefan Tullius, MD, 617-697-9294, stullius@bwh.harvard.edu
About this study
Our study will explore the feasibility of initiating a deceased donor uterine transplant program in addition to the existing living donor IRB at BWH.
Using the template established by teams around the world, we will identify emotionally and socially stable females of reproductive age with intact ovaries who are unable to gestate a child due to congenital or acquired uterine factor infertility. After careful screening, participants will undergo egg harvest, in vitro fertilization, and embryo cryopreservation using standard methods. Women who successfully complete the fertilization of at least six euploid embryos will be eligible to be placed on the waitlist for a deceased donor uterus transplant. After a successful transplant and a period of observation to ensure normal menstrual cycle and graft viability (anticipate six months), embryo implantation will be undertaken.
Read more
Following an embryo transfer, gestation will be carefully monitored by our high-risk pregnancy specialists. Medical research interventions include the surgical implantation of a uterus utilizing techniques by teams that have applied this approach successfully, close post-transplant follow up including immunosuppression therapy tailored to established standards during pregnancy minimizing fetal risks, and careful management of pregnancy. After childbearing is complete (at most two gestations), the donor uterus will be removed either during Cesarean or during an elective procedure. In addition, open ended interviews and surveys will be conducted to elicit ethical and psychosocial concerns arising from the experience of subjects and their families, health care providers, and the wider community. The investigator's intent is to monitor outcomes for transplant recipients as well as the live born infants for 30 days after removal of the transplanted uterus.
It is estimated that the time from screening to a potential live birth will be a minimum of 22 months, but likely between 24 - 36 months depending on organ availability.
- Conditions
- Infertility of Uterine Origin
- Being tested
- Uterine Transplant from Deceased Donor
- Keywords
- AUFI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Transplant from Deceased DonorProcedure or surgery
The recipient will be started on anti-rejection medications (as is routine for transplant recipients) prior to the OR. Standard of care anesthesia and line placement will take place. The recipient will be appropriately identified as an organ recipient and the donor organ identified per required transplant protocols already in place. The recipient team will then connect the vasculature and appropriate supporting structures for the uterus transplant. Once the organ has been re-perfused, the remainder of the operation will take place and the patient will be moved to the Intensive Care Unit and later to the transplant patient floor for standard monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Deceased Donor Uterus Transplant | Experimental | Not described Receives: Procedure: Uterine Transplant from Deceased Donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Live Births Following Uterus Transplant
To provide motherhood options for women with AUIF as an alternative to surrogacy or adoption, via gestating and giving birth via Cesarean section to a live infant.
Measured: Within 5 years of transplant
Number of Surgically Successful Uterus Transplants
To achieve surgically successful uterus transplants.
Measured: Within 3 months of transplant
Secondary outcomes (2)
Financial impact of deceased donor uterus transplantation
To analyze the overall impact of deceased donor uterus transplantation costs relative to established alternative procedures such as adoption and surrogacy.
Measured: Through Study completion, up to 5 years post transplant
Quality of life impact of deceased donor uterus transplantation
To analyze the overall impact of deceased donor uterus transplantation including changes in quality of life, relative to other established alternative procedures such as adoption and surrogacy.
Measured: Through study completion, up to 5 years post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infertility of Uterine OriginStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan G Tullius, Brigham and Women's Hospital
- Investigators
- Stefan G Tullius, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026893
- Sponsor's protocol ID
- 2018P001782/PHS
- Status last verified
- Sep 2026
- First submitted
- 2 May 2019
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be published or presented at scientific meetings or distributed upon request.
Publications
Brannstrom M, Johannesson L, Dahm-Kahler P, Enskog A, Molne J, Kvarnstrom N, Diaz-Garcia C, Hanafy A, Lundmark C, Marcickiewicz J, Gabel M, Groth K, Akouri R, Eklind S, Holgersson J, Tzakis A, Olausson M. First clinical uterus transplantation trial: a six-month report. Fertil Steril. 2014 May;101(5):1228-36. doi: 10.1016/j.fertnstert.2014.02.024. Epub 2014 Feb 27.
PubMed 24582522Tullius SG, Rudolf JA, Malek SK. Moving boundaries--the Nightingale twins and transplantation science. N Engl J Med. 2012 Apr 26;366(17):1564-5. doi: 10.1056/NEJMp1114193. No abstract available.
PubMed 22533575Lefkowitz A, Edwards M, Balayla J. The Montreal Criteria for the Ethical Feasibility of Uterine Transplantation. Transpl Int. 2012 Apr;25(4):439-47. doi: 10.1111/j.1432-2277.2012.01438.x. Epub 2012 Feb 23.
PubMed 22356169Del Priore G, Saso S, Meslin EM, Tzakis A, Brannstrom M, Clarke A, Vianna R, Sawyer R, Smith JR. Uterine transplantation--a real possibility? The Indianapolis consensus. Hum Reprod. 2013 Feb;28(2):288-91. doi: 10.1093/humrep/des406. Epub 2012 Nov 30.
PubMed 23202992McKay DB, Josephson MA. Pregnancy in recipients of solid organs--effects on mother and child. N Engl J Med. 2006 Mar 23;354(12):1281-93. doi: 10.1056/NEJMra050431. No abstract available.
PubMed 16554530
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)
- ClinicalTrials.gov ID
- NCT04026893
- Acronym / sponsor ID
- 2018P001782/PHS
- Conditions
- Infertility of Uterine Origin
- Keywords
- AUFI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study will explore the feasibility of initiating a deceased donor uterine transplant program in addition to the existing living donor IRB at BWH.
Using the template established by teams around the world, we will identify emotionally and socially stable females of reproductive age with intact ovaries who are unable to gestate a child due to congenital or acquired uterine factor infertility. After careful screening, participants will undergo egg harvest, in vitro fertilization, and embryo cryopreservation using standard methods. Women who successfully complete the fertilization of at least six euploid embryos will be eligible to be placed on the waitlist for a deceased donor uterus transplant. After a successful transplant and a period of observation to ensure normal menstrual cycle and graft viability (anticipate six months), embryo implantation will be undertaken.
Following an embryo transfer, gestation will be carefully monitored by our high-risk pregnancy specialists. Medical research interventions include the surgical implantation of a uterus utilizing techniques by teams that have applied this approach successfully, close post-transplant follow up including immunosuppression therapy tailored to established standards during pregnancy minimizing fetal risks, and careful management of pregnancy. After childbearing is complete (at most two gestations), the donor uterus will be removed either during Cesarean or during an elective procedure. In addition, open ended interviews and surveys will be conducted to elicit ethical and psychosocial concerns arising from the experience of subjects and their families, health care providers, and the wider community. The investigator's intent is to monitor outcomes for transplant recipients as well as the live born infants for 30 days after removal of the transplanted uterus.
It is estimated that the time from screening to a potential live birth will be a minimum of 22 months, but likely between 24 - 36 months depending on organ availability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deceased Donor Uterus Transplant | Experimental | Procedure: Uterine Transplant from Deceased Donor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine Transplant from Deceased DonorThe recipient will be started on anti-rejection medications (as is routine for transplant recipients) prior to the OR. Standard of care anesthesia and line placement will take place. The recipient will be appropriately identified as an organ recipient and the donor organ identified per required transplant protocols already in place. The recipient team will then connect the vasculature and appropriate supporting structures for the uterus transplant. Once the organ has been re-perfused, the remainder of the operation will take place and the patient will be moved to the Intensive Care Unit and later to the transplant patient floor for standard monitoring. | Procedure or surgery | Deceased Donor Uterus Transplant |
Primary outcome
Number of Live Births Following Uterus Transplant
Time frame: Within 5 years of transplant
To provide motherhood options for women with AUIF as an alternative to surrogacy or adoption, via gestating and giving birth via Cesarean section to a live infant.
Number of Surgically Successful Uterus Transplants
Time frame: Within 3 months of transplant
To achieve surgically successful uterus transplants.
2 secondary outcomes
Financial impact of deceased donor uterus transplantation
Time frame: Through Study completion, up to 5 years post transplant
Quality of life impact of deceased donor uterus transplantation
Time frame: Through study completion, up to 5 years post transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 24582522Brannstrom M, Johannesson L, Dahm-Kahler P, Enskog A, Molne J, Kvarnstrom N, Diaz-Garcia C, Hanafy A, Lundmark C, Marcickiewicz J, Gabel M, Groth K, Akouri R, Eklind S, Holgersson J, Tzakis A, Olausson M. First clinical uterus transplantation trial: a six-month report. Fertil Steril. 2014 May;101(5):1228-36. doi: 10.1016/j.fertnstert.2014.02.024. Epub 2014 Feb 27.
- Background: PubMed 22533575Tullius SG, Rudolf JA, Malek SK. Moving boundaries--the Nightingale twins and transplantation science. N Engl J Med. 2012 Apr 26;366(17):1564-5. doi: 10.1056/NEJMp1114193. No abstract available.
- Background: PubMed 22356169Lefkowitz A, Edwards M, Balayla J. The Montreal Criteria for the Ethical Feasibility of Uterine Transplantation. Transpl Int. 2012 Apr;25(4):439-47. doi: 10.1111/j.1432-2277.2012.01438.x. Epub 2012 Feb 23.
- Background: PubMed 23202992Del Priore G, Saso S, Meslin EM, Tzakis A, Brannstrom M, Clarke A, Vianna R, Sawyer R, Smith JR. Uterine transplantation--a real possibility? The Indianapolis consensus. Hum Reprod. 2013 Feb;28(2):288-91. doi: 10.1093/humrep/des406. Epub 2012 Nov 30.
- Background: PubMed 16554530McKay DB, Josephson MA. Pregnancy in recipients of solid organs--effects on mother and child. N Engl J Med. 2006 Mar 23;354(12):1281-93. doi: 10.1056/NEJMra050431. No abstract available.
- Individual participant dataSharing planned: Yes. Data will be published or presented at scientific meetings or distributed upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan G Tullius, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Transplant from Deceased Donor in people with Infertility of Uterine Origin, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan G Tullius, MD (617-732-6866, stullius@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Live Births Following Uterus Transplant (time frame: Within 5 years of transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026893, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.