Attitudes and Decision Regret Regarding Fertility Preservation in Transgender Individuals

NCT07194226 | Completed

• 1 other identifier: Fertilitrans_v1
• Study Type: observational
• Target: 616
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Preservation in Transgender Persons

Keywords

Fertility preservation; Decision regret; Transgender adults; Gender-affirming treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, approximately three months.

Secondary Outcomes (4)

• Frequency of Main Motivations for Fertility Preservation Decision

  Through study completion, approximately three months.

• Counseling Modalities and Satisfaction

  Through study completion, approximately three months.

• Barriers to Fertility Preservation and Psychological Impact

  Through study completion, approximately three months.

• Preferences and Attitudes Toward Counseling and Fertility Preservation

  Through study completion, approximately three months.

Interventions

No intervention (observational study) OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified transgender individuals of any sex assigned at birth, at any stage of gender affirmation
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 26, 2025
• Study Start: March 29, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-07

Locations

IT (1)