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Recruiting

NCT Number: NCT06953908

The Copenhagen Gender Identity Cohort

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Center for Gender Identity

Copenhagen, Denmark

Location status: Recruiting

Location contact

Christina E Fonvig, Ph.D.

CONTACT

[email protected]

004535456854

Malene Hilden, MD, Ph.d.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to read and understand Danish

Treatment and study plan

Primary outcomes

  1. Assessment of quality of life

    Time frame: Baseline and latest yearly assessment.

    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)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: KIK

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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