Absolute Uterine Factor InfertilityRobot2NCT05089513
Uterus Transplantation by Robotics - Gothenburg III
A study testing Robotic surgery in people with Absolute Uterine Factor Infertility, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
Robotic assisted organ procurement and robotic assisted transplantation in live donor uterus transplantation Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Absolute Uterine Factor Infertility
- What is being tested?
- Robotic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesSweden
- Study dates
- 21 Oct 2021to 30 Aug 2022
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Uterine factor infertility, age 18-38 years, psychological stable, in steady relationship.
Who cannot join
- Smoking, systemic disease, psychological instability
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska
Gothenburg, None Selected, 41345
Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: Uterus Transplantation by Robotics and in Donor and Recipient
Robotic assisted organ procurement and robotic assisted transplantation in live donor uterus transplantation
Read the detailed description
Inclusion; absolute uterine factor infertility, age between 18 and 38, BMI less than 28, non-smoker
- Conditions
- Absolute Uterine Factor Infertility
- Being tested
- Robotic surgery
- Keywords
- uterus, infertility, transplantation, robotics
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgeryProcedure or surgery
Robotoc surgery (Da Vinci) in both donor and recipient
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery | Experimental | Robotic surgery in both live donor and recipient Receives: Procedure: Robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success
Uterus with viability and regular menstruations
Measured: 0-4 months
Secondary outcomes (1)
Pregnancy rate
Pregnancy rate per ET
Measured: 10-48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start21 Oct 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Why it stopped: slow recruitment
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
- Masking
- None (open label)
- Enrolment
- 2 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089513
- Sponsor's protocol ID
- Robot 2
- Acronym
- Robot2
- Status last verified
- Jun 2024
- First submitted
- 14 Oct 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only group dat will be published and shared after publication, in order to avoid identification of a person
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterus Transplantation by Robotics and in Donor and Recipient
- ClinicalTrials.gov ID
- NCT05089513
- Acronym / sponsor ID
- Robot2 / Robot 2
- Conditions
- Absolute Uterine Factor Infertility
- Keywords
- uterus, infertility, transplantation, robotics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 22 Oct 2021 (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.
Robotic assisted organ procurement and robotic assisted transplantation in live donor uterus transplantation
Detailed description
Inclusion; absolute uterine factor infertility, age between 18 and 38, BMI less than 28, non-smoker
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery | Experimental | Procedure: Robotic surgeryRobotic surgery in both live donor and recipient |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Uterine factor infertility, age 18-38 years, psychological stable, in steady relationship.
Key exclusion criteria (1 listed)
- Smoking, systemic disease, psychological instability
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 |
|---|---|---|
| Robotic surgeryRobotoc surgery (Da Vinci) in both donor and recipient | Procedure or surgery | Robotic surgery |
Primary outcome
Surgical success
Time frame: 0-4 months
Uterus with viability and regular menstruations
1 secondary outcome
Pregnancy rate
Time frame: 10-48 months
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No. Only group dat will be published and shared after publication, in order to avoid identification of a person
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic surgery in people with Absolute Uterine Factor Infertility, 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 1 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: stopped early, as of the sponsor's last update on 24 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 was stopped early (reason given: slow recruitment). Results are not available in the source record.
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?
Surgical success (time frame: 0-4 months). 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 24 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.