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NCT Number: NCT06710496

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

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.

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Key information

Conditions

Pregnancy Behavior Comorbidities and Coexisting Conditions Drugs Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gender Affirmation Surgery Genital Diseases Genital Diseases, Female Gynecological Disorders Gynecological Surgery Hormone Replacement Therapy Smoking Smoking Behavior Testosterone Replacement Therapy Transgender Men Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

irccs azienda ospedaliero universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location contact

Alessandra Lami, PhD Student

CONTACT

[email protected]

+393343097975

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

analysis of medical records

Other

analysis of medical records of the patients

Primary outcomes

  1. histological description of genital organs

    Time frame: 6 months

Secondary outcomes

  1. prevalence of malignant and benign gynecological pathology

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Cristina Meriggiola, Associate Professor

CONTACT

[email protected]

+390512144391

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

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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