Attitudes and Decision Regret Regarding Fertility Preservation in Transgender Individuals

NCT ID: NCT07194226

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 616 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-29
• Study Completion Date: 2025-05-31

Brief 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. 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).

Conditions

Fertility Preservation in Transgender Persons

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

No intervention (observational study)

This is an observational survey; participants complete an anonymous questionnaire and no medical or behavioral intervention is applied.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Self-identified as transgender
• Age ≥ 18 years.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Maria Cristina Meriggiola

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, Italy

Countries

Italy

Other Identifiers

Fertilitrans_v1

Identifier Type: -

Identifier Source: org_study_id