Actively Recruiting

Age: 0 - 18Years
All Genders
ID06573177

Gender Incongruence in Danish Youth (GenDa): An Observational Cohort Study of Children and Adolescents Referred to a National Gender Identity Service

Led by Rigshospitalet, Denmark · Updated on 2024-08-27

1300

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study investigates the health care program for Danish children and adolescents with gender incongruence, established in January 2016. It aims to characterize psychosocial profiles, development history, and treatment paths, while evaluating biological and psychosocial outcomes. The study focuses on growth, bone health, body composition, metabolic and hormone levels, mental health conditions like autism and psychiatric diagnoses, as well as social factors such as family environment and education. Participants are referred to a national gender identity service that includes specialized clinics for sexology, child and adolescent mental health, and growth and reproduction. The study monitors biological parameters before and during hormonal treatments like gonadotropin-releasing hormone analogues and cross-sex hormones. A biobank is also being established for those receiving hormone treatments to support future research. During the study, participants undergo assessments of body mass index, puberty status, bone mineral content, body fat and lean mass, hormone levels, blood pressure, reproductive organ ultrasounds, sperm analysis, psychiatric conditions, functioning levels, and suicide risk. These measurements are tracked over eight years to improve understanding of treatment effects and psychosocial well-being. The study also collects demographic and cultural data to support comprehensive analysis of health outcomes and quality of life.

CONDITIONS

Brief Title

Optimizing Individual Health Care for Young People With Gender Incongruence

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Accepted referral to the gender identity service
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 8 years

Participants who undergo routine care at the gender identity service are observed over time to collect health and psychosocial data.

Periodic visits as part of routine care

Trial Site Locations

Total: 1 location

1

Department of Growth and Reproduction, Rigshospitalet

Copenhagen, Capital Region, Denmark, 2100

Actively Recruiting

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Research Team

K

Katharina M Main

A

Annamaria GE Giraldi

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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