Mrk AnomalyGOT-BMC-UTxNCT03590405
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC
A study testing uterus transplantation surgery and IVF in people with Mrk Anomaly and Infertility, Female, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mrk Anomaly, Infertility, Female
- What is being tested?
- uterus transplantation surgery and IVF
- 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
- 15 Jun 2018to 1 Dec 2021
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age < 38 years
- psychologicaly stable
- BMI < 35
- no systemic disease
- no standing medication
- in a stable relationship or married
Show all 16Show fewer
- normal ovarian reserve
- absolute uterine factor infertility
- normal kidney function
- close relative to recipient
- age < 60 years
- normal pregnancies
- maximum two cesarean sections
- BMI < 35
- no major systemic disease
- no previous major surgery
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
Official title: Uterus Transplantation LD - Feasibility Study - Sahlgrenska - Bellevue Medical Centre
Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.
Read the detailed description
Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery.
Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut
- Conditions
- Mrk Anomaly, Infertility, Female
- Being tested
- uterus transplantation surgery and IVF
- Keywords
- uterus, infertility, transplantation
- Medical subject headings
- Mullerian aplasia, Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterus transplantation surgery and IVFProcedure or surgery
IVF before surgery living donor uterus transplantation ET
| Study group | Role | What they receive |
|---|---|---|
| uterus transplantation | Experimental | uterus transplantation from living donor with the donor being close relative Receives: Procedure: uterus transplantation surgery and IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth
live birth
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 posted18 Jul 2018
- Study start15 Jun 2018
- 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 Mrk AnomalyStudies 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
- Collaborators
- Saint Joseph University, at Bellevue Medical Centre
- Responsible party
- Principal investigator, Mats Brännström, Sahlgrenska University Hospital
- Investigators
- Mats Brännström, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590405
- Sponsor's protocol ID
- Sahlgrenska-BMC-UTx
- Acronym
- GOT-BMC-UTx
- Status last verified
- Dec 2021
- First submitted
- 17 Jun 2018
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Uterus Transplantation LD - Feasibility Study - Sahlgrenska - Bellevue Medical Centre
- ClinicalTrials.gov ID
- NCT03590405
- Acronym / sponsor ID
- GOT-BMC-UTx / Sahlgrenska-BMC-UTx
- Conditions
- Mrk Anomaly, Infertility, Female
- Keywords
- uterus, infertility, transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Saint Joseph University, at Bellevue Medical Centre
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 18 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.
Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.
Detailed description
Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery.
Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uterus transplantation | Experimental | Procedure: uterus transplantation surgery and IVFuterus transplantation from living donor with the donor being close relative |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- age < 38 years
- psychologicaly stable
- BMI < 35
- 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 transplantation surgery and IVFIVF before surgery living donor uterus transplantation ET | Procedure or surgery | uterus transplantation |
Primary outcome
live birth
Time frame: 3 years
live birth
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
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
Sahlgrenska University Hospital
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 surgery and IVF in people with Mrk Anomaly and Infertility, Female, 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 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 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?
live birth (time frame: 3 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; AzTrials last refreshed its copy on 6 Nov 2026.