Resolve InfertilityNCT03048396
Acceptance of Uterus Transplantation
A study testing Uterus transplantation in people with Resolve Infertility, run by University Hospital Tuebingen.
Trial summary
Transplantation of an uterus Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Resolve Infertility
- What is being tested?
- Uterus transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2030
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age below 40 years
- absolute uterine factor infertility
- BMI < 30
Who cannot join
- systemic disease
- psychiatric disease
About this study
Official title: Transplantation of an Uterus for Treatment of an Absolute Uterine Infertility
Transplantation of an uterus
Read the detailed description
Uterus transplantation will be performed from live donors to patients with absolute uterine factor infertility. Organ procurement from the donor will be performed by laparotomy. Transplantation will also be performed by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy.
- Conditions
- Resolve Infertility
- Being tested
- Uterus transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterus transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Uterus transplantation | Experimental | Not described Receives: Procedure: Uterus transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who are interested in an uterus transplantation
Measured: 3 years
Number of patients from these who do have a potential donor
Measured: 3 years
Number of patients from these who do have a medical indication for an uterus transplantation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startOct 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resolve InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Brucker, MD, Principal investigator, Research Institute for Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048396
- Sponsor's protocol ID
- FEH_Uterustransplantation
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2016
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brucker SY, Brannstrom M, Taran FA, Nadalin S, Konigsrainer A, Rall K, Scholler D, Henes M, Bosmuller H, Fend F, Nikolaou K, Notohamiprodjo M, Rosenberger P, Grasshoff C, Heim E, Kramer B, Reisenauer C, Hoopmann M, Kagan KO, Dahm-Kahler P, Kvarnstrom N, Wallwiener D. Selecting living donors for uterus transplantation: lessons learned from two transplantations resulting in menstrual functionality and another attempt, aborted after organ retrieval. Arch Gynecol Obstet. 2018 Mar;297(3):675-684. doi: 10.1007/s00404-017-4626-z. Epub 2017 Dec 21.
PubMed 29270725
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of an Uterus for Treatment of an Absolute Uterine Infertility
- ClinicalTrials.gov ID
- NCT03048396
- Acronym / sponsor ID
- FEH_Uterustransplantation
- Conditions
- Resolve Infertility
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Transplantation of an uterus
Detailed description
Uterus transplantation will be performed from live donors to patients with absolute uterine factor infertility. Organ procurement from the donor will be performed by laparotomy. Transplantation will also be performed by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterus transplantation | Experimental | Procedure: Uterus transplantation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age below 40 years
- absolute uterine factor infertility
- BMI < 30
Key exclusion criteria (2 listed)
- systemic disease
- psychiatric disease
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 |
|---|---|---|
| Uterus transplantation | Procedure or surgery | Uterus transplantation |
Primary outcome
Number of patients who are interested in an uterus transplantation
Time frame: 3 years
Number of patients from these who do have a potential donor
Time frame: 3 years
Number of patients from these who do have a medical indication for an uterus transplantation
Time frame: 3 years
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 26 Jan 2026.
- Derived from this study: PubMed 29270725Brucker SY, Brannstrom M, Taran FA, Nadalin S, Konigsrainer A, Rall K, Scholler D, Henes M, Bosmuller H, Fend F, Nikolaou K, Notohamiprodjo M, Rosenberger P, Grasshoff C, Heim E, Kramer B, Reisenauer C, Hoopmann M, Kagan KO, Dahm-Kahler P, Kvarnstrom N, Wallwiener D. Selecting living donors for uterus transplantation: lessons learned from two transplantations resulting in menstrual functionality and another attempt, aborted after organ retrieval. Arch Gynecol Obstet. 2018 Mar;297(3):675-684. doi: 10.1007/s00404-017-4626-z. Epub 2017 Dec 21.
- Individual participant dataSharing planned: No
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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.
Sara Brucker, MD principal investigator
Research Institute for Women's Health
Questions about this trial
What is this clinical trial studying?
A study testing Uterus transplantation in people with Resolve Infertility, run by University Hospital Tuebingen.
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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who are interested in an uterus transplantation (time frame: 3 years). The study lists 3 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 NCT03048396, which also lists 1 linked publication.
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 26 Jan 2026.