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Gender IncongruenceNCT06573177

Optimizing Individual Health Care for Young People With Gender Incongruence

An observational study of Gender Incongruence, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Gender Incongruence
What is being tested?
Referral to the gender identity service.
How many people
1,300 participants
Where
1 siteDenmark
Study dates
1 Jan 2022to Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • Child, Adult

Study population: All children and youngsters under the age of 18 years referred to the gender identity service in Denmark.

Who may be able to join

  • Accepted referral to the gender identity service.

Who cannot join

  • None.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Katharina M Main contact

+4535455085

katharina.main@regionh.dk

Annamaria GE Giraldi contact

annamaria.giraldi@regionh.dk

Denmark1 site, 1 recruiting

  • Department of Growth and Reproduction, Rigshospitalet

    Copenhagen, Capital Region, 2100

    Katharina M Main, +4535455085, katharina.main@regionh.dk

    Recruiting

Other trials in Denmark

About this study

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

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:

Read more
  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.

Being tested
Referral to the gender identity service.
Medical subject headings
Gender Dysphoria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Referral to the gender identity service.Other

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index (BMI)

    BMI will be calculated from height and weight (kg/m^2) measurements

    Measured: 8 years

  2. Puberty

    Tanner stages of puberty (1-5) are obtained by clinical examination

    Measured: 8 years

  3. Bone mineral content (BMD)

    Whole body dual-energy x-ray absorptiometry (DXA) will determine BMD Z-score for age and sex

    Measured: 8 years

  4. Body fat

    Whole body dual-energy x-ray absorptiometry (DXA) will measure body fat percentage (%)

    Measured: 8 years

  5. Lean body mass

    Whole body dual-energy x-ray absorptiometry (DXA) will measure lean mass (kg)

    Measured: 8 years

  6. Reproductive serum hormone levels

    Changes in reproductive hormone levels (%)

    Measured: 8 years

  7. Adrenal serum hormone levels

    Changes in adrenal hormone levels (%)

    Measured: 8 years

  8. Blood pressure

    Changes in blood pressure measurement (mm Hg)

    Measured: 8 years

  9. Transabdominal ultrasound of uterus

    Changes of endometrium (thickness in mm) during testosterone treatment

    Measured: 8 years

  10. Transabdominal ultrasound of ovaries

    Change in number of follicles (n) during testosterone treatment

    Measured: 8 years

  11. Sperm count

    Sperm Count (at cryopreservation)

    Measured: 8 years

  12. Sperm motility

    Sperm motility (at cryopreservation)

    Measured: 8 years

  13. Morbidity

    Number of participants with registered ICD10 diagnoses

    Measured: 8 years

  14. Demographic characteristics

    eg. socioeconomic status

    Measured: 8 years

  15. Prevalence of psychiatric disorders

    Based on screening for psychopathology using validated tests, as indicated:

    Schedule for Affective Disorders and Schizophrenia for School-age children (K-SADS):

    A diagnostic tool used to assess psychiatric disorders in children and adolescents. It is a semi-structured interview guide used to identify psychiatric conditions.

    Wechsler Intelligence Scale for Children (WISC 4/5) or Wechsler Adult Intelligence Scale (WAIS 4): General cognitive function is measured on a scale from 40-160 which is used as an intelligence quotient. A higher score: A higher cognitive function.

    Rorschach: A projective psychological test. The test uses a series of ink blots to evaluate a person's mental functions and emotional state by analysing their perceptions of the figures. The test is based on complex and subjective scoring and interpretation.

    Measured: 8 years

  16. Prevalence of Attention Deficit Hyperactive Disorder (ADHD)

    Screening using validated tests:

    Behavior Rating Inventory of Executive Function (BRIEF): General executive function is measured on a normative scale with T-scores from 20-80. A higher score: more executive difficulties.

    Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS): Attention Deficit Hyperactive Disorder traits measured on a normative scale with T-scores from 0-78. A higher score: More Attention Deficit Hyperactive Disorder traits

    Measured: 8 years

  17. Prevalence of autism spectrum disorder

    Screening using validated tests:

    Social Responsiveness Scale (SRS): Autism spectrum disorder (ASD) traits measured on a scale with T-scores from 0-76+. A higher score: More autistic traits.

    Autism Diagnostic Observation Schedule (ADOS): A structured observational tool to assess ASD. A trait is rated on a scale from 0 to 3. 0 indicates absence of a behaviour and 3 indicates severe occurrence of a behaviour. The total score determines the presence and severity of ASD. The cut-off scores are 10 for autism and 7 for ASD traits.

    Autism Diagnostic Interview-Revised (ADI-R): A structured interview used to assess ASD traits. Interview questions are scored on a scale from 0-3. 0 indicates absence of a behaviour and 3 indicates severe occurrence of a behaviour. The scores compared with cut-off values determine the presence of ASD. Cut-off values for each trait: Social interaction: cut-off 10; Communication skills: cut-off 8; Restrictive and repetitive behaviour patterns: cut-off 3.

    Measured: 8 years

  18. Global level of functioning

    Children's Global Assessment Scale (C-GAS, range 1-100)

    Measured: 8 years

  19. Psychosocial Disability

    Global Assessment of Psychosocial Disability (GAPD, range 0-8)

    Measured: 8 years

  20. Suicide risk

    Number of participants with self-reported suicide thoughts or attempts (interview)

    Measured: 8 years

  21. Substance abuse.

    Number participants with self-reported abuse of alcohol, drugs or medications (interview)

    Measured: 8 years

  22. Personal history of gender incongruence (GI)

    Age at onset of GI and social transitioning (interview)

    Measured: 8 years

  23. Cultural measures

    Interviews with youngsters and their families to explore:

    1. The experiences that are influential in the process of seeking gender-affirming treatment. 2) Treatment expectations and wishes. 3) The cultural understandings of gender, sex, body and identity that inform the decision to seek treatment. 4) The role of the family in the decision to seek treatment.

    Measured: 8 years

  24. Establishment of biobank

    Serum, plasma, DNA at -20 and -80 degrees Celsius.

    Measured: 8 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start1 Jan 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06573177
Sponsor's protocol ID
H-18050607
Status last verified
Aug 2024
First submitted
18 Apr 2024
Last updated
27 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gender Incongruence, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katharina M Main (+4535455085, katharina.main@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (BMI) (time frame: 8 years). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06573177.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.

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