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Clinical Trials/NCT06710496
NCT06710496
Not yet recruiting
Not Applicable

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country100 target enrollmentDecember 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment
100
Locations
1
Primary Endpoint
histological description of genital organs
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2024
End Date
December 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Cristina Meriggiola

Professor Maria Cristina Meriggiola

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Eligibility Criteria

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

Outcomes

Primary Outcomes

histological description of genital organs

Time Frame: 6 months

Secondary Outcomes

  • prevalence of malignant and benign gynecological pathology(6 months)

Study Sites (1)

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