The Copenhagen Gender Identity Cohort

NCT06953908 | Recruiting

• 1 other identifier: 001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to systematically collect data on adults seeking medical and surgical treatments for gender incongruence. This prospective, longitudinal cohort aims to generate insights into the safety, effectiveness, and overall satisfaction with current treatments. Additionally, the study seeks to identify areas for improvement and support healthcare professionals in making informed decisions. Most importantly, it aims to enhance the quality of life for transgender and gender-diverse individuals by ensuring that the care they receive aligns with their needs and goals. Participants will include patients seeking treatment at the Copenhagen Center for Gender Identity, Denmark. Data collection will be both clinician- and patient-reported. Participants will be asked to complete online surveys at baseline, after the assessment process, and annually if they initiate hormone therapy. The study will systematically gather information on gender identity and transition experiences, sociodemographics, self-medication, health status, self-reported quality of life, and treatment preferences. Additionally, detailed records of treatment courses and specific interventions will be collected from all involved healthcare providers across specialties. The study will evaluate the effects of different treatment options, both in the short and long term. It will explore how quality of life is associated with gender identity, transition, sociodemographics, lifestyle, and health, as well as assess the medical impact of various treatments, including counseling, hormone therapy, and surgery. Furthermore, the study will investigate the prevalence of side effects and complications related to treatment, as well as factors influencing treatment discontinuation, including cases of detransition. Finally, the project will focus on quality indicators such as waiting times and patient satisfaction, contributing to the ongoing development of high-quality, patient-centered care for transgender and gender-diverse individuals.

Conditions

Gender Identity; Gender Dysphoria, Adult; Gender Incongruence

Keywords

Gender Identity; Gender Incongruence

Outcome Measures

Primary Outcomes (1)

• Assessment of quality of life

  The study uses the WHOQOL-BREF to assesses quality of life (QOL). The repeated assessment provides a snapshot of quality of life, allowing for the exploration of associations with other factors. The WHOQOL-BREF is scored from 0-100, with higher values indicating increased quality of life. Change from baseline in the four domains (Physical Helath, Psychological, Relationships, Environment) to the latest recorded yearly assessment recorded within the study period (10 years from 2022-2032)

  Baseline and latest yearly assessment.

Study Arms (1)

Adults seeking help regarding gender incongruence

All patients referred to The Center of Gender Identity in Copenhagen (CGI), 18 years or older, seeking medical og surgical treatment for gender incongruence.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants must be deemed eligible for assessment at The Center for Gender Identity in Copenhagen.

You may qualify if:

• All patients referred to The Center for Gender Identity in Copenhagen

You may not qualify if:

• Inability to read and understand Danish

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

The Center for Gender Identity

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research associate

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: May 1, 2025
• Study Start: February 1, 2022
• Primary Completion (Estimated): January 31, 2032
• Study Completion (Estimated): January 31, 2032
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)