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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:
This study will help doctors and counselors improve fertility-preservation advice for transgender adults in Italy.
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:
Methods & Questionnaire
This cross-sectional, observational survey will enroll ≥600 transgender adults (≥18 years) via:
The questionnaire covers:
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:
Additional Analyses: sensitivity checks for missing data (imputation), interaction/subgroup analyses (e.g., changes in relationship or finances).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention (observational study) | Other | This is an observational survey; participants complete an anonymous questionnaire and no medical or behavioral intervention is applied. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, approximately three months. |
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Inclusion Criteria:
Exclusion Criteria:
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Self-identified transgender individuals of any sex assigned at birth, at any stage of gender affirmation
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | BO | 40138 | Italy |
IPD will be shared upon reasonable request.
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 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. |
| Through study completion, approximately three months. |
| Barriers to Fertility Preservation and Psychological Impact | Percentage and types of difficulties reported during gamete preservation and use. | 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. | Through study completion, approximately three months. |