Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Accepted referral to the gender identity service
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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