跳至主要内容
临床试验/NCT06710496
NCT06710496尚未招募不适用

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
histological description of genital organs

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • previous gynecological surgery
  • previous gynecological disorder diagnosis

结局指标

主要结局

histological description of genital organs

时间窗: 6 months

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Cristina Meriggiola

Professor Maria Cristina Meriggiola

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (1)

Loading locations...

相似试验

HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS... | 临床试验