Focus: Uterus Transplant ProcedureNCT06799728
Uterus Transplantation: Acceptability of the Procedure in Eligible Patients
An observational study of Focus: Uterus Transplant Procedure and Acceptability of the Uterus Transplantation Procedure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This study aims to define the knowledge and acceptability of uterine transplantation in patients suffering from infertility due to congenital or acquired absence of this organ, which are followed up in the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Focus: Uterus Transplant Procedure, Acceptability of the Uterus Transplantation Procedure
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 5 Apr 2021to 5 Apr 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The subjects to be enrolled in the study are patients taken care of at the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Orsola-Malpighi and/or registered with the Italian Association for Androgen Insensitivity Syndrome and similar conditions-AISIA.
Who may be able to join
- - age 18-44 years
- patients with AUFI (MRKH, CAIS, previous hysterectomy due to benign/malignant/unfavorable obstetric outcome) and currently under treatment at the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Orsola-Malpighi and registered with the Italian Association for Androgen Insensitivity and Similar Conditions-AISIA.
- Informed consent
- Networked electronic device ensuring connection to the platform and subsequent questionnaire filling
- Internet network
- Personal email address, to which the link for filling out the questionnaires will be sent
Who cannot join
- no exclusion criteria are provided
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Unioversitaria di Bologna
Bologna, Bologna, 40138
About this study
This study aims to define the knowledge and acceptability of uterine transplantation in patients suffering from infertility due to congenital or acquired absence of this organ, which are followed up in the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Orsola-Malpighi and registered with the Italian Association for Androgen Insensitivity and Similar Conditions-AISIA.
Read the detailed description
Absolute infertility from uterine factor (AUFI) is the term used to indicate the condition of women who cannot achieve pregnancy due to congenital or acquired absence of the uterus or the presence of an anatomically or physiologically non-functional utery1.
The causes of AUFI can be classified in primary/congenital (Mayer-Rokitansky-Kuster-Hauser-MRKH syndrome, Complete insensitivity to androgens-CAIS) and secondary/acquired (Asherman syndrome, previous hysterectomy for benign/malignant gynecological pathologies).
This condition was considered without therapeutic options until a few years ago, when the first birth from living donor uterus transplant was obtained (Sweden, 2014)2.
There are many challenges to the transplantation of the uterus:
- Ethical, complex and evolving issues: first of all the acceptability by patients;3
- the definition of inclusion criteria for donors and recipients, based on the results of procedures carried out to date;4
- the presence of the donor: deceased or living, and in the latter the use of minimally invasive surgical techniques5.
Primary objective of the study Define the acceptability of the uterus transplant procedure in the target population through a cross-sectional observational study using a targeted questionnaire.
Secondary objective To assess the knowledge of certain aspects of uterine transplantation among the population affected by SVCD. To identify the opinion and needs of the study population.
Expected results The information will help improve the efficiency and quality of health services for people with SVD.
- Keywords
- Transplantation of the uterus
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
In detail, the first part of the questionnaire contains a series of questions concerning socio-demographic aspects, pathological and family history, lifestyles, health status and perceived quality of life. In addition, the following structured and validated questionnaire will be required:
- Brief Symptom Checklist-BSCL (Scale from 0 to 4)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start5 Apr 2021
- Primary completion5 Apr 2024
- Study completion5 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Uterus Transplant ProcedureStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria C Meriggiola, MD, Principal investigator, IRCCS Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799728
- Sponsor's protocol ID
- ACCUTX-20
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterus Transplantation: Acceptability of the Procedure in Eligible Patients
- ClinicalTrials.gov ID
- NCT06799728
- Acronym / sponsor ID
- ACCUTX-20
- Keywords
- Transplantation of the uterus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2026 (estimated)
- First posted
- 29 Jan 2025 (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.
This study aims to define the knowledge and acceptability of uterine transplantation in patients suffering from infertility due to congenital or acquired absence of this organ, which are followed up in the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Orsola-Malpighi and registered with the Italian Association for Androgen Insensitivity and Similar Conditions-AISIA.
Detailed description
Absolute infertility from uterine factor (AUFI) is the term used to indicate the condition of women who cannot achieve pregnancy due to congenital or acquired absence of the uterus or the presence of an anatomically or physiologically non-functional utery1.
The causes of AUFI can be classified in primary/congenital (Mayer-Rokitansky-Kuster-Hauser-MRKH syndrome, Complete insensitivity to androgens-CAIS) and secondary/acquired (Asherman syndrome, previous hysterectomy for benign/malignant gynecological pathologies).
This condition was considered without therapeutic options until a few years ago, when the first birth from living donor uterus transplant was obtained (Sweden, 2014)2.
There are many challenges to the transplantation of the uterus:
- Ethical, complex and evolving issues: first of all the acceptability by patients;3
- the definition of inclusion criteria for donors and recipients, based on the results of procedures carried out to date;4
- the presence of the donor: deceased or living, and in the latter the use of minimally invasive surgical techniques5.
Primary objective of the study Define the acceptability of the uterus transplant procedure in the target population through a cross-sectional observational study using a targeted questionnaire.
Secondary objective To assess the knowledge of certain aspects of uterine transplantation among the population affected by SVCD. To identify the opinion and needs of the study population.
Expected results The information will help improve the efficiency and quality of health services for people with SVD.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The subjects to be enrolled in the study are patients taken care of at the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Orsola-Malpighi and/or registered with the Italian Association for Androgen Insensitivity Syndrome and similar conditions-AISIA.
Key inclusion criteria (6 listed)
- - age 18-44 years
- patients with AUFI (MRKH, CAIS, previous hysterectomy due to benign/malignant/unfavorable obstetric outcome) and currently under treatment at the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Orsola-Malpighi and registered with the Italian Association for Androgen Insensitivity and Similar Conditions-AISIA.
- Informed consent
- Networked electronic device ensuring connection to the platform and subsequent questionnaire filling
- Internet network
Key exclusion criteria (1 listed)
- no exclusion criteria are provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire
Time frame: 1 year
In detail, the first part of the questionnaire contains a series of questions concerning socio-demographic aspects, pathological and family history, lifestyles, health status and perceived quality of life. In addition, the following structured and validated questionnaire will be required: - Brief Symptom Checklist-BSCL (Scale from 0 to 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- 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.
Maria C Meriggiola, MD principal investigator
IRCCS Bologna
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 Focus: Uterus Transplant Procedure and Acceptability of the Uterus Transplantation Procedure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Questionnaire (time frame: 1 year). 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 29 Jan 2025.