Clinical trial NCT06953908: The Copenhagen Gender Identity Cohort
Official title: The Copenhagen Gender Identity Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gender Identity
Gender Dysphoria, Adult
Gender Incongruence
Keywords: Gender Identity
Gender Incongruence
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants must be deemed eligible for assessment at The Center for Gender Identity in Copenhagen.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Inability to read and understand Danish

Primary outcomes:
measure: Assessment of quality of life
timeFrame: Baseline and latest yearly assessment.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Center for Gender Identity
Study officials:
References: