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Not yet recruiting NCT06710496

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

Observational Pregnancy Smoking Behavior Testosterone Replacement Therapy Drugs

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: analysis of medical records.
Who it may be relevant to
Registry conditions: Pregnancy, Smoking Behavior, Testosterone Replacement Therapy, Drugs. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other analysis of medical records
    analysis of medical records of the patients

Primary outcome measures

  • histological description of genital organs [Time frame: 6 months]
Secondary outcome measures (1)
  • prevalence of malignant and benign gynecological pathology [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • irccs azienda ospedaliero universitaria di Bologna — Bologna

Identifiers

NCT: NCT06710496 · ISTO-AFAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗