IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138, Italy
NCT Number: NCT07194226
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.
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Notify Me18 year and older
All sexes
Observational
Bologna, BO, 40138, 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).
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an observational survey; participants complete an anonymous questionnaire and no medical or behavioral intervention is applied.
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.
Time frame: Through study completion, approximately three months.
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.
Time frame: Through study completion, approximately three months.
Distribution of counseling types received (modality and provider) and participants' satisfaction ratings regarding the adequacy and helpfulness of fertility-preservation counseling.
Time frame: Through study completion, approximately three months.
Percentage and types of difficulties reported during gamete preservation and use.
Time frame: Through study completion, approximately three months.
Participants' expressed preferences and attitudes regarding counselling on fertility-preservation options.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Acronym: Fertilitrans
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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