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

NCT ID: NCT06710496

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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transgender afab histology

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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AFAB TG

assigned female at birth transgender people undergoing gender affirming surgery during testosterone therapy

analysis of medical records

Intervention Type OTHER

analysis of medical records of the patients

Interventions

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analysis of medical records

analysis of medical records of the patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Maria Cristina Meriggiola

Professor Maria Cristina Meriggiola

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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irccs azienda ospedaliero universitaria di Bologna

Bologna, Emilia-Romagna, Italy

Site Status

Countries

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Italy

Central Contacts

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Maria Cristina Meriggiola, Associate Professor

Role: CONTACT

Phone: +390512144391

Email: [email protected]

Facility Contacts

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Alessandra Lami, PhD Student

Role: primary

Other Identifiers

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ISTO-AFAB

Identifier Type: -

Identifier Source: org_study_id