The Copenhagen Gender Identity Cohort

NCT ID: NCT06953908

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2032-01-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Inability to read and understand Danish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Christina Esmann Fonvig

Research associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Center for Gender Identity

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Facility Contacts

Christina E Fonvig, Ph.D.

Role: primary

kik.rigshospitalet@regionh.dk

004535456854

Malene Hilden, MD, Ph.d.

Role: backup

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id