Absolute Uterine Factor InfertilityNCT03581019
Uterus Transplantation From Deceased Donor - Gothenburg III
A study testing uterus transplantation in people with Absolute Uterine Factor Infertility and Transplantation, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Absolute Uterine Factor Infertility, Transplantation, Mrk Anomaly
- 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
- 1 participants
- Where
- 2 sitesSweden
- Study dates
- 17 Jun 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- initially included with IVF and excluded by donor issues of Gothenburg I or II
- initially included and excluded by early graft failure of Gothenburg I or II
- age < 40 years
- no systemic disease
- no standing medication
- satisfactory ovarian reserve
Show all 16Show fewer
- BMI <35 and at BMI 30-35 waist circumference of < 82 cm
- absolute uterine factor infertility
- psychological stable
- brain death and suitable as multiorgan donor
- acceptance for donation of uterus from family or previously by patient
- age <55 years
- at least one normal pregnancy and childbirth
- no previos malignancy
- no systemic disease
- no previous major surgery inn abdomen or on uterus
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg, 41345
Mats Brännström
Gothenburg, SE-41345
About this study
Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II
- Being tested
- uterus transplantation
- Keywords
- infertility, uterus, transplantation, MRKH
- Medical subject headings
- Mullerian aplasia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterus transplantationProcedure or surgery
uterus transplantation from deceased donor
| Study group | Role | What they receive |
|---|---|---|
| Uterus transplantation | Experimental | Uterus transplantation Receives: Procedure: uterus transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
birth of healthy child
Measured: 1-5 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start17 Jun 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absolute Uterine Factor InfertilityStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University 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
- Model description
- Observational study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mats Brännström, Sahlgrenska University Hospital
- Investigators
- Mats Brännström, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581019
- Sponsor's protocol ID
- Sahlgrenska-DD-UTx
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2018
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterus Transplantation From Deceased Donor - Gothenburg III
- ClinicalTrials.gov ID
- NCT03581019
- Acronym / sponsor ID
- Sahlgrenska-DD-UTx
- Keywords
- infertility, uterus, transplantation, MRKH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 17 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Jul 2018 (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.
Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational study
| Arm | Type | Receives |
|---|---|---|
| Uterus transplantation | Experimental | Procedure: uterus transplantationUterus transplantation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- initially included with IVF and excluded by donor issues of Gothenburg I or II
- initially included and excluded by early graft failure of Gothenburg I or II
- age < 40 years
- no systemic disease
- no standing medication
Key exclusion criteria (0 listed)
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 transplantationuterus transplantation from deceased donor | Procedure or surgery | Uterus transplantation |
Primary outcome
birth of healthy child
Time frame: 1-5 years after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Related trials for Absolute Uterine Factor Infertility
Recruiting
Uterine Transplant for Women With Absolute Uterine Factor Infertility (AUFI)
Mayer Rokitansky Kuster Hauser Syndrome, Absence of Uterus
Active, not recruiting
Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility
Absolute Uterine Infertility
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. This study is not recruiting at the moment.
Mats Brännström principal investigator
Göteborg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterus transplantation in people with Absolute Uterine Factor Infertility and Transplantation, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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 16 inclusion and 0 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: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
birth of healthy child (time frame: 1-5 years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024.