Fertility Preservation in Transgender PersonsFertilitransNCT07194226
Attitudes and Decision Regret Regarding Fertility Preservation in Transgender Individuals
An observational study of Fertility Preservation in Transgender Persons, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational survey is to learn how transgender adults think and feel about saving their fertility before gender-affirming treatment. We will ask at least 300 participants in Emilia-Romagna to answer an anonymous online questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fertility Preservation in Transgender Persons
- How many people
- 616 participants
- Where
- 1 siteItaly
- Study dates
- 29 Mar 2025to 31 May 2025
- 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
- Adult, Older adult
Study population: The study population consists of adult transgender individuals followed in routine clinical practice at the Unit of Gynecology and Human Reproduction Pathophysiology, IRCCS AOU Bologna, and the general transgender population of the Emilia-Romagna region reached via questionnaire distribution in the atria of UNIBO departmental buildings and through social-media networks.
Who may be able to join
- Self-identified as transgender
- Age ≥ 18 years.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138
About this study
The goal of this observational survey is to learn how transgender adults think and feel about saving their fertility before gender-affirming treatment. We will ask at least 300 participants in Emilia-Romagna to answer an anonymous online questionnaire. The main questions are:
- Why did people choose or decline fertility preservation?
- How much regret do they feel about their decision?
- What counseling or support did they receive, and was it helpful?
- What personal or financial factors influenced their choice?
This study will help doctors and counselors improve fertility-preservation advice for transgender adults in Italy.
Read the detailed description
Background \& Rationale
For transgender individuals, fertility is particularly complex because gender-affirming treatments such as hormone therapy, hysterectomy, or orchiectomy can permanently impact reproductive potential. At our center, fertility preservation through gamete (egg or sperm) or gonadal tissue cryopreservation is routinely offered before initiating these treatments.
However, no studies in Italy have explored why transgender individuals choose to preserve or not preserve fertility, nor how satisfied or regretful they feel about these choices afterward. Understanding the motivations, barriers, and emotional outcomes around these decisions is crucial to providing truly informed, person-centered counseling that respects transgender individuals' reproductive autonomy and supports their overall quality of life.
This study aims to fill this gap by exploring these critical aspects within the Italian transgender community to improve fertility-preservation counseling practices.
Study Objectives \& Hypotheses
Primary Objective: Measure decision regret (5-item Decision Regret Scale) and identify factors-such as counseling quality and life changes-that predict higher regret.
Hypothesis: Higher regret scores will be found in those declining preservation or receiving less comprehensive counseling.
Secondary Objectives:
- Characterize primary motivations (e.g., cost, family support) behind preservation decisions.
- Describe counseling experiences by modality (in-person vs. telehealth), provider type, and satisfaction.
- Document barriers (medical, financial, logistical, dysphoria-related) encountered during preservation or use of gametes.
- Assess participants' preferences and attitudes toward future fertility-preservation counseling and procedures.
Methods \& Questionnaire
This cross-sectional, observational survey will enroll ≥600 transgender adults (≥18 years) via:
- Clinical Recruitment: routine care patients at the Unit of Gynecology and Human Reproduction Pathophysiology, IRCCS AOU Bologna
- Community Recruitment: anonymous REDCap questionnaire distributed in UNIBO departmental atria and through regional social-media outlets
The questionnaire covers:
- Demographics \& Transition History (age, sex assigned at birth, gender identity, education, employment, hormone/surgery timeline)
- Fertility-Preservation Decision
- For those who preserved: procedure type, timing, encountered difficulties, satisfaction, and non-use reasons.
- For those who did not: main reasons and attitudes toward future preservation.
- Counseling Experience: modality, provider role, and satisfaction rating.
- Decision Regret Scale (DRS, 5-item): validated measure of post-decision regret.
- Psychosocial Context: relationship status, social support, economic situation, and life satisfaction.
Statistical Analysis Plan Primary Outcome (DRS): compute mean, SD, and distribution; compare by preservation status (t-test) and counseling quality (ANOVA); multivariate linear regression adjusting for age, support, and other covariates.
Secondary Outcomes:
- Motivations: report proportions; analyze associations with regret (chi-square, logistic regression).
- Counseling Satisfaction: summarize frequencies; correlate with DRS.
- Barriers: tabulate reported obstacles; test relationships with psychological impact (chi-square).
- Preferences \& Attitudes: describe proportions and conduct subgroup comparisons.
Additional Analyses: sensitivity checks for missing data (imputation), interaction/subgroup analyses (e.g., changes in relationship or finances).
- Being tested
- No intervention (observational study)
- Keywords
- Fertility preservation, Decision regret, Transgender adults, Gender-affirming treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This is an observational survey; participants complete an anonymous questionnaire and no medical or behavioral intervention is applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Regret Scale (DRS) Score (5-Item)
Scores collected with the 5-item Decision Regret Scale to assess participants' levels of regret about their fertility-preservation choice. Includes analysis of regret frequency by type and quality of counseling received and identification of personal factors (e.g., marital status, social support) that may have contributed to regret.
Measured: Through study completion, approximately three months.
Secondary outcomes (4)
Frequency of Main Motivations for Fertility Preservation Decision
Frequency of the primary reasons (e.g., cost, family support, personal priorities) for choosing or declining fertility preservation and their association with Decision Regret Scale scores.
Measured: Through study completion, approximately three months.
Counseling Modalities and Satisfaction
Distribution of counseling types received (modality and provider) and participants' satisfaction ratings regarding the adequacy and helpfulness of fertility-preservation counseling.
Measured: Through study completion, approximately three months.
Barriers to Fertility Preservation and Psychological Impact
Percentage and types of difficulties reported during gamete preservation and use.
Measured: Through study completion, approximately three months.
Preferences and Attitudes Toward Counseling and Fertility Preservation
Participants' expressed preferences and attitudes regarding counselling on fertility-preservation options.
Measured: Through study completion, approximately three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start29 Mar 2025
- Primary completion31 May 2025
- Study completion31 May 2025
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 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
- Cross-sectional
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Cristina Meriggiola, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194226
- Sponsor's protocol ID
- Fertilitrans_v1
- Acronym
- Fertilitrans
- Status last verified
- Jul 2025
- First submitted
- 29 Aug 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes and Decision Regret Regarding Fertility Preservation in Transgender Individuals
- ClinicalTrials.gov ID
- NCT07194226
- Acronym / sponsor ID
- Fertilitrans / Fertilitrans_v1
- Keywords
- Fertility preservation, Decision regret, Transgender adults, Gender-affirming treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 26 Sep 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.
The goal of this observational survey is to learn how transgender adults think and feel about saving their fertility before gender-affirming treatment. We will ask at least 300 participants in Emilia-Romagna to answer an anonymous online questionnaire. The main questions are:
- Why did people choose or decline fertility preservation?
- How much regret do they feel about their decision?
- What counseling or support did they receive, and was it helpful?
- What personal or financial factors influenced their choice?
This study will help doctors and counselors improve fertility-preservation advice for transgender adults in Italy.
Detailed description
Background \& Rationale
For transgender individuals, fertility is particularly complex because gender-affirming treatments such as hormone therapy, hysterectomy, or orchiectomy can permanently impact reproductive potential. At our center, fertility preservation through gamete (egg or sperm) or gonadal tissue cryopreservation is routinely offered before initiating these treatments.
However, no studies in Italy have explored why transgender individuals choose to preserve or not preserve fertility, nor how satisfied or regretful they feel about these choices afterward. Understanding the motivations, barriers, and emotional outcomes around these decisions is crucial to providing truly informed, person-centered counseling that respects transgender individuals' reproductive autonomy and supports their overall quality of life.
This study aims to fill this gap by exploring these critical aspects within the Italian transgender community to improve fertility-preservation counseling practices.
Study Objectives \& Hypotheses
Primary Objective: Measure decision regret (5-item Decision Regret Scale) and identify factors-such as counseling quality and life changes-that predict higher regret.
Hypothesis: Higher regret scores will be found in those declining preservation or receiving less comprehensive counseling.
Secondary Objectives:
- Characterize primary motivations (e.g., cost, family support) behind preservation decisions.
- Describe counseling experiences by modality (in-person vs. telehealth), provider type, and satisfaction.
- Document barriers (medical, financial, logistical, dysphoria-related) encountered during preservation or use of gametes.
- Assess participants' preferences and attitudes toward future fertility-preservation counseling and procedures.
Methods \& Questionnaire
This cross-sectional, observational survey will enroll ≥600 transgender adults (≥18 years) via:
- Clinical Recruitment: routine care patients at the Unit of Gynecology and Human Reproduction Pathophysiology, IRCCS AOU Bologna
- Community Recruitment: anonymous REDCap questionnaire distributed in UNIBO departmental atria and through regional social-media outlets
The questionnaire covers:
- Demographics \& Transition History (age, sex assigned at birth, gender identity, education, employment, hormone/surgery timeline)
- Fertility-Preservation Decision
- For those who preserved: procedure type, timing, encountered difficulties, satisfaction, and non-use reasons.
- For those who did not: main reasons and attitudes toward future preservation.
- Counseling Experience: modality, provider role, and satisfaction rating.
- Decision Regret Scale (DRS, 5-item): validated measure of post-decision regret.
- Psychosocial Context: relationship status, social support, economic situation, and life satisfaction.
Statistical Analysis Plan Primary Outcome (DRS): compute mean, SD, and distribution; compare by preservation status (t-test) and counseling quality (ANOVA); multivariate linear regression adjusting for age, support, and other covariates.
Secondary Outcomes:
- Motivations: report proportions; analyze associations with regret (chi-square, logistic regression).
- Counseling Satisfaction: summarize frequencies; correlate with DRS.
- Barriers: tabulate reported obstacles; test relationships with psychological impact (chi-square).
- Preferences \& Attitudes: describe proportions and conduct subgroup comparisons.
Additional Analyses: sensitivity checks for missing data (imputation), interaction/subgroup analyses (e.g., changes in relationship or finances).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult transgender individuals followed in routine clinical practice at the Unit of Gynecology and Human Reproduction Pathophysiology, IRCCS AOU Bologna, and the general transgender population of the Emilia-Romagna region reached via questionnaire distribution in the atria of UNIBO departmental buildings and through social-media networks.
Key inclusion criteria (2 listed)
- Self-identified as transgender
- Age ≥ 18 years.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No intervention (observational study)This is an observational survey; participants complete an anonymous questionnaire and no medical or behavioral intervention is applied. | Other | – |
Primary outcome
Decision Regret Scale (DRS) Score (5-Item)
Time frame: Through study completion, approximately three months.
Scores collected with the 5-item Decision Regret Scale to assess participants' levels of regret about their fertility-preservation choice. Includes analysis of regret frequency by type and quality of counseling received and identification of personal factors (e.g., marital status, social support) that may have contributed to regret.
4 secondary outcomes
Frequency of Main Motivations for Fertility Preservation Decision
Time frame: Through study completion, approximately three months.
Counseling Modalities and Satisfaction
Time frame: Through study completion, approximately three months.
Barriers to Fertility Preservation and Psychological Impact
Time frame: Through study completion, approximately three months.
Preferences and Attitudes Toward Counseling and Fertility Preservation
Time frame: Through study completion, approximately three months.
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 26 Sep 2025.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon reasonable request.
Related trials for Fertility Preservation in Transgender Persons
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 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 26 Sep 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?
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?
Decision Regret Scale (DRS) Score (5-Item) (time frame: Through study completion, approximately three 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 26 Sep 2025.