Fertility Preservation in Transgender PersonsNCT05120245
Fertility Preservation in Transgender Persons: a Retrospective Look
An observational study of Fertility Preservation in Transgender Persons, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Patients in this study will be asked how they feel about the decision to freeze gametes, using a validated questionnaire. In addition, a number of questions with free text fields will be included in the questionnaire to write down any reasons for their satisfaction or regret. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fertility Preservation in Transgender Persons
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jul 2021to 30 Jun 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: transgender personen
Who may be able to join
- Dutch speaking
- Sperm or oocyte preservation between june 2015 and june 2020. Survey in 2021
Who cannot join
- Ovarian and testicular tissue cryopreservation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fertility Preservation in Transgender Persons: a Retrospective Look At the Decision and a Survey of the Desire for Children.
Patients in this study will be asked how they feel about the decision to freeze gametes, using a validated questionnaire. In addition, a number of questions with free text fields will be included in the questionnaire to write down any reasons for their satisfaction or regret. In a second part, the intention to use the frozen material will be assessed. We focus on techniques with real perspectives (e.g. cryopreservation of oocytes and sperm cells) and not on techniques that are more experimental for later use (cryopreservation of ovarian and testicular tissue).
What is being measured
The primary outcome is the main question the study is designed to answer.
Transgender people's retrospective view of the decision
Study of transgender persons' retrospective evaluation of the decision to freeze egg or sperm cells prior to gender-confirming hormonal or surgical treatment in transition
Measured: fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)
Satisfaction/ regret about the decision
Survey on the reasons for satisfaction/ regret regarding the decision to freeze egg cells or sperm cells prior to gender-confirming hormonal or surgical treatment in the context of transition
Measured: fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)
Intention
Examination of the intention to use the frozen egg cells or sperm cells to fulfil a desire to have children
Measured: fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start8 Jul 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility Preservation in Transgender PersonsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stoop, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120245
- Sponsor's protocol ID
- BC-09136
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation in Transgender Persons: a Retrospective Look At the Decision and a Survey of the Desire for Children.
- ClinicalTrials.gov ID
- NCT05120245
- Acronym / sponsor ID
- BC-09136
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Nov 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.
Patients in this study will be asked how they feel about the decision to freeze gametes, using a validated questionnaire. In addition, a number of questions with free text fields will be included in the questionnaire to write down any reasons for their satisfaction or regret. In a second part, the intention to use the frozen material will be assessed. We focus on techniques with real perspectives (e.g. cryopreservation of oocytes and sperm cells) and not on techniques that are more experimental for later use (cryopreservation of ovarian and testicular tissue).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- transgender personen
Key inclusion criteria (2 listed)
- Dutch speaking
- Sperm or oocyte preservation between june 2015 and june 2020. Survey in 2021
Key exclusion criteria (1 listed)
- Ovarian and testicular tissue cryopreservation
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
Transgender people's retrospective view of the decision
Time frame: fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)
Study of transgender persons' retrospective evaluation of the decision to freeze egg or sperm cells prior to gender-confirming hormonal or surgical treatment in transition
Satisfaction/ regret about the decision
Time frame: fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)
Survey on the reasons for satisfaction/ regret regarding the decision to freeze egg cells or sperm cells prior to gender-confirming hormonal or surgical treatment in the context of transition
Intention
Time frame: fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)
Examination of the intention to use the frozen egg cells or sperm cells to fulfil a desire to have children
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Fertility Preservation in Transgender Persons
Active, not recruitingObservational study
Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy
Gender Dysphoria, Transgender
Active, not recruitingObservational study
Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy
Gender Dysphoria, Transgender
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.
Stoop principal investigator
University Hospital, Ghent
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 Fertility Preservation in Transgender Persons, run by University Hospital, Ghent at 1 site in Belgium.
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 2 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 19 Sep 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 Belgium. 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?
Transgender people's retrospective view of the decision (time frame: fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)). The study lists 3 primary outcomes in all. 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 19 Sep 2024.