Absolute Uterine Factor InfertilityUTx-twinNCT03138226
Living Donor Uterus Transplantation Between Identical Twins
An observational study of Absolute Uterine Factor Infertility and Cervical Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Absolute Uterine Factor Infertility, Cervical Cancer
- What is being tested?
- uterus transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2017to 1 Dec 2021
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Adult
Study population: absolute uterine factor infertility - monozygotic twin
Who may be able to join
- age below 40 years
- absolute uterine factor infertility
- BMI<30-
Who cannot join
- systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.
Read the detailed description
Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.
- Being tested
- uterus transplantation
- Keywords
- uterus, transplantation, infertility, twin
- Medical subject headings
- Uterine Cervical Neoplasms, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterus transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Live births after uterus transplantation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Jan 2017
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, University of Belgrade
- Responsible party
- Principal investigator, Mats Brännström, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138226
- Sponsor's protocol ID
- Twin UTx
- Acronym
- UTx-twin
- Status last verified
- Dec 2021
- First submitted
- 30 Apr 2017
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Published in articles
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Donor Uterus Transplantation Between Identical Twins
- ClinicalTrials.gov ID
- NCT03138226
- Acronym / sponsor ID
- UTx-twin / Twin UTx
- Keywords
- uterus, transplantation, infertility, twin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, University of Belgrade
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 May 2017 (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.
Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.
Detailed description
Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- absolute uterine factor infertility - monozygotic twin
Key inclusion criteria (3 listed)
- age below 40 years
- absolute uterine factor infertility
- BMI<30-
Key exclusion criteria (1 listed)
- systemic 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 | – |
Primary outcome
Live births after uterus transplantation
Time frame: 5 years
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 15 Dec 2021.
- Individual participant dataSharing planned: No. Published in articles
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Absolute Uterine Factor Infertility and Cervical Cancer, run by Sahlgrenska University Hospital at 1 site 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 3 inclusion and 1 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 15 Dec 2021. 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 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?
Live births after uterus transplantation (time frame: 5 years). 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 15 Dec 2021.