Clinical trial NCT06573177: Optimizing Individual Health Care for Young People With Gender Incongruence
Official title: Gender Incongruence in Danish Youth (GenDa): An Observational Cohort Study of Danish Children and Adolescents Referred to a National Gender Identity Service
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gender Incongruence
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 1300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All children and youngsters under the age of 18 years referred to the gender identity service in Denmark.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Accepted referral to the gender identity service.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 8 years
measure: Puberty
timeFrame: 8 years
measure: Bone mineral content (BMD)
timeFrame: 8 years
measure: Body fat
timeFrame: 8 years
measure: Lean body mass
timeFrame: 8 years
measure: Reproductive serum hormone levels
timeFrame: 8 years
measure: Adrenal serum hormone levels
timeFrame: 8 years
measure: Blood pressure
timeFrame: 8 years
measure: Transabdominal ultrasound of uterus
timeFrame: 8 years
measure: Transabdominal ultrasound of ovaries
timeFrame: 8 years
measure: Sperm count
timeFrame: 8 years
measure: Sperm motility
timeFrame: 8 years
measure: Morbidity
timeFrame: 8 years
measure: Demographic characteristics
timeFrame: 8 years
measure: Prevalence of psychiatric disorders
timeFrame: 8 years
measure: Prevalence of Attention Deficit Hyperactive Disorder (ADHD)
timeFrame: 8 years
measure: Prevalence of autism spectrum disorder
timeFrame: 8 years
measure: Global level of functioning
timeFrame: 8 years
measure: Psychosocial Disability
timeFrame: 8 years
measure: Suicide risk
timeFrame: 8 years
measure: Substance abuse.
timeFrame: 8 years
measure: Personal history of gender incongruence (GI)
timeFrame: 8 years
measure: Cultural measures
timeFrame: 8 years
measure: Establishment of biobank
timeFrame: 8 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Growth and Reproduction, Rigshospitalet
state: Capital Region
Study officials:
affiliation: Rigshospitalet, Denmark
name: Katharina M Main
role: PRINCIPAL_INVESTIGATOR
References: