Infertility, FemaleUTX-robotNCT02987023
Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II
An observational study of Infertility, Female, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be by laparotomy. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- uterus transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2016to Dec 2021
- How long will I take part?
- 7 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: absolute uterine factor infertile women > 38 years
Who may be able to join
- age below 38 years
- absolute uterine factor infertility
- BMI<30
Who cannot join
- systemic disease
- psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be 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,
Read the detailed description
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be 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
- Infertility, Female
- Being tested
- uterus transplantation
- Keywords
- infertility, uterus, transplantation
- Medical subject headings
- Infertility, Female, 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 live donor
What is being measured
The primary outcome is the main question the study is designed to answer.
Live births after uterus transplantation
Assessed by records from birthing unit and Swedish National Birth registry
Measured: 5 years
Secondary outcomes (1)
Development of children after uterus transplantation
Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV)
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2021
- Study completionDec 2021
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, FemaleStudies 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
- 8 participants (actual)
- Target duration
- 7 Years
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, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987023
- Sponsor's protocol ID
- SahlgrenskaUTx
- Acronym
- UTX-robot
- Status last verified
- Jun 2024
- First submitted
- 29 Nov 2016
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual data will not be shared.
Publications
Dahm-Kahler P, Kvarnstrom N, Brannstrom M. Robotic live donor hysterectomy. Curr Opin Organ Transplant. 2021 Dec 1;26(6):640-645. doi: 10.1097/MOT.0000000000000926.
PubMed 34593704Brannstrom M, Kvarnstrom N, Groth K, Akouri R, Wiman L, Enskog A, Dahm-Kahler P. Evolution of surgical steps in robotics-assisted donor surgery for uterus transplantation: results of the eight cases in the Swedish trial. Fertil Steril. 2020 Nov;114(5):1097-1107. doi: 10.1016/j.fertnstert.2020.05.027. Epub 2020 Aug 19.
PubMed 32828495Brannstrom M, Dahm-Kahler P, Ekberg J, Akouri R, Groth K, Enskog A, Broecker V, Molne J, Ayoubi JM, Kvarnstrom N. Outcome of Recipient Surgery and 6-Month Follow-Up of the Swedish Live Donor Robotic Uterus Transplantation Trial. J Clin Med. 2020 Jul 22;9(8):2338. doi: 10.3390/jcm9082338.
PubMed 32707899Wentz E, Hagberg B, Hagberg H, Bokstrom H, Brannstrom M. Uterus transplantation; first data on neurologic, neuropsychiatric, and physical examination follow-up of children up to 6 years of age. Hum Reprod. 2025 Dec 1;40(12):2419-2429. doi: 10.1093/humrep/deaf178.
PubMed 40971624Brannstrom M, Dahm-Kahler P, Kvarnstrom N, Enskog A, Olofsson JI, Olausson M, Molne J, Akouri R, Jarvholm S, Nilsson L, Stigson L, Hagberg H, Bokstrom H. Reproductive, obstetric, and long-term health outcome after uterus transplantation: results of the first clinical trial. Fertil Steril. 2022 Sep;118(3):576-585. doi: 10.1016/j.fertnstert.2022.05.017. Epub 2022 Jun 11.
PubMed 35697530
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 From Live Donors With Robotic Assisted Surgery - Gothenburg II
- ClinicalTrials.gov ID
- NCT02987023
- Acronym / sponsor ID
- UTX-robot / SahlgrenskaUTx
- Conditions
- Infertility, Female
- Keywords
- infertility, uterus, transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 8 Dec 2016 (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.
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be 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,
Detailed description
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- absolute uterine factor infertile women > 38 years
Key inclusion criteria (3 listed)
- age below 38 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 transplantationUterus transplantation from live donor | Procedure or surgery | – |
Primary outcome
Live births after uterus transplantation
Time frame: 5 years
Assessed by records from birthing unit and Swedish National Birth registry
1 secondary outcome
Development of children after uterus transplantation
Time frame: 8 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 24 Jun 2024.
- Background: PubMed 34593704Dahm-Kahler P, Kvarnstrom N, Brannstrom M. Robotic live donor hysterectomy. Curr Opin Organ Transplant. 2021 Dec 1;26(6):640-645. doi: 10.1097/MOT.0000000000000926.
- Background: PubMed 32828495Brannstrom M, Kvarnstrom N, Groth K, Akouri R, Wiman L, Enskog A, Dahm-Kahler P. Evolution of surgical steps in robotics-assisted donor surgery for uterus transplantation: results of the eight cases in the Swedish trial. Fertil Steril. 2020 Nov;114(5):1097-1107. doi: 10.1016/j.fertnstert.2020.05.027. Epub 2020 Aug 19.
- Background: PubMed 32707899Brannstrom M, Dahm-Kahler P, Ekberg J, Akouri R, Groth K, Enskog A, Broecker V, Molne J, Ayoubi JM, Kvarnstrom N. Outcome of Recipient Surgery and 6-Month Follow-Up of the Swedish Live Donor Robotic Uterus Transplantation Trial. J Clin Med. 2020 Jul 22;9(8):2338. doi: 10.3390/jcm9082338.
- Derived from this study: PubMed 40971624Wentz E, Hagberg B, Hagberg H, Bokstrom H, Brannstrom M. Uterus transplantation; first data on neurologic, neuropsychiatric, and physical examination follow-up of children up to 6 years of age. Hum Reprod. 2025 Dec 1;40(12):2419-2429. doi: 10.1093/humrep/deaf178.
- Derived from this study: PubMed 35697530Brannstrom M, Dahm-Kahler P, Kvarnstrom N, Enskog A, Olofsson JI, Olausson M, Molne J, Akouri R, Jarvholm S, Nilsson L, Stigson L, Hagberg H, Bokstrom H. Reproductive, obstetric, and long-term health outcome after uterus transplantation: results of the first clinical trial. Fertil Steril. 2022 Sep;118(3):576-585. doi: 10.1016/j.fertnstert.2022.05.017. Epub 2022 Jun 11.
- Individual participant dataSharing planned: No. Individual data will not be shared.
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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. This study is not recruiting at the moment.
Mats Brännström, MD, PhD principal investigator
Göteborg University
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 Infertility, Female, 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 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: finished, 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 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?
On the ClinicalTrials.gov record for NCT02987023, 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 24 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.