HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS ASSIGNED TO FEMALES AT BIRTH UNDERGOING GENDER AFFIRMATION SURGERY AND IN TESTOSTERONE THERAPY

Not yet recruiting

• Conditions: Pregnancy; Smoking Behavior; Drugs; Comorbidities and Coexisting Conditions; Testosterone Replacement Therapy; Gynecological Surgery; Transgender Men; Gender Affirmation Surgery; Hormone Replacement Therapy; Gynecological Disorders

• Registration Number: NCT06710496
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of gender affirming hormone therapy with testosterone on these organs and to evaluate the incidence of benign and malign gynecological pathology in AFAB transgender people.

Detailed Description

This retrospective, observational, single-center study aims to analyze histological data obtained from the analysis of ovaries, fallopian tubes, uterine body, endometrium, and cervix of assigned female at birth (AFAB) transgender individuals who underwent gender affirming surgey (GAS) with hysterectomy and bilateral adnexectomy or hysterectomy alone following the administration of exogenous Testosterone (T). Histological results of the genital organs removed during GAS can provide important information about the effects and safety of loong term T treatment on these organs. Data on this subject is scarce in the literature. For this reason, even today, pathologists have not been able to establish guidelines for describing the histological results obtained from these patients.Furthermore, this analysis will evaluate the incidence of benign and malignant gynecological pathology in AFAB transgender people.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Study Start: 2024-12
• Primary Completion: 2025-02
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• gender incongruence diagnosis
• people assigned female at birth
• age >18 years
• gender affirming surgery with hysterectomy
• testosterone therapy

Exclusion Criteria

• previous gynecological surgery
• previous gynecological disorder diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
histological description of genital organs	6 months

Secondary Outcome Measures

Name	Time	Method
prevalence of malignant and benign gynecological pathology	6 months

Trial Locations

Locations (1)

irccs azienda ospedaliero universitaria di Bologna; 🇮🇹 Bologna, Emilia Romagna, Italy