The Copenhagen Gender Identity Cohort (KIK)

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.

Study Overview

• Status: Recruiting
• Conditions: Gender Identity; Gender Incongruence; Gender Dysphoria, Adult

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • The Center for Gender Identity
    • Contact: Christina E Fonvig, Ph.D.; Phone Number: 004535456854; Email: kik.rigshospitalet@regionh.dk
    • Contact: Malene Hilden, MD, Ph.d.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to read and understand Danish

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): January 31, 2032
• Study Completion (Estimated): January 31, 2032

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Gender Identity; Gender Incongruence
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing of individual participant data (IPD) is in conflict with Danish GDPR regulations, as it involves the transfer of personal and potentially sensitive information, which is restricted under Danish data protection laws to safeguard individuals' privacy and ensure compliance with strict legal and ethical requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No