Optimizing Individual Health Care for Young People With Gender Incongruence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Referral to the gender identity service..
- Who it may be relevant to
- Registry conditions: Gender Incongruence. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gender Incongruence in Danish Youth (GenDa): An Observational Cohort Study of Danish Children and Adolescents Referred to a National Gender Identity Service
Overview
This observational study focuses on evaluating the effect of the current health care program for Danish children and adolescents with gender incongruence, which was established in January 2016. Somatic outcome parameters include growth, bone health, body composition, metabolic parameters, hormone levels and concurrent diseases. Psychosocial parameters include the trajectory of gender incongruence development, mental health, i.e. autism spectrum disorders, behavioural problems, self-harm, suicidal ideation and psychiatric diagnoses, and social context, i.e. family demographics, education, minority stress. This study aims to: 1. Characterise the psychosocial profile of all children and adolescents referred for treatment, as well as the history of gender identity development and treatment trajectories. 2. Systematically evaluate biological parameters before and during hormonal treatment with gonadotropin-releasing hormone (GnRH) analogues and cross-sex hormones, and to establish a biobank for those in hormone treatment. The investigators hypothesise that intervention with counselling and hormonal treatment is safe and has a positive impact on psychosocial well-being of transgender youngsters. The overall aim is to provide data for improving future family counselling, clinical care, patient satisfaction, patient safety and ultimately quality-of-life.
Interventions
- Other Referral to the gender identity service.
Referral to the national gender identity service consisting of the Sexological Clinic, Child and Adolescent Mental Health Center, and Department of Growth and Reproduction in the Capital Region of Denmark.
Primary outcome measures
- Body Mass Index (BMI) [Time frame: 8 years]
- Puberty [Time frame: 8 years]
- Bone mineral content (BMD) [Time frame: 8 years]
- Body fat [Time frame: 8 years]
- Lean body mass [Time frame: 8 years]
- Reproductive serum hormone levels [Time frame: 8 years]
- Adrenal serum hormone levels [Time frame: 8 years]
- Blood pressure [Time frame: 8 years]
- Transabdominal ultrasound of uterus [Time frame: 8 years]
- Transabdominal ultrasound of ovaries [Time frame: 8 years]
Eligibility criteria
Inclusion criteria
- Accepted referral to the gender identity service.
Exclusion criteria
- None.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Department of Growth and Reproduction, Rigshospitalet — Copenhagen
Identifiers
NCT: NCT06573177 · H-18050607