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Brain development, brain functioning, growth and metabolic aspects in the clinical management of transsexual adolescents

Brain development, brain functioning, growth and metabolic aspects in the clinical management of transsexual adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN81574253
Enrollment
264
Registered
2007-05-02
Start date
2007-02-01
Completion date
Unknown
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transsexuality Mental and Behavioural Disorders Transsexuality

Interventions

Patients: Measurements will be performed at a prepubertal stage, before start of GnRH analogue Triptoreline/Decapeptyl-CR (current puberty delaying medication for transsexual adolescen
method used: a. voxel-based morphometry b. Region Of Interest (ROI) analysis 2. Functional MRI (Blood Oxygenation Level-Dependent [BOLD]) during which t

Sponsors

Vrije University Medical Centre (VUMC) (The Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria - pubertal patients: 1. Girls and boys with transsexualism who are eligible for sex reassignment according to psychologist and psychiatrist (if they are older than 12 years, psychologically stable and live in a stable social environment) 2. Girls have to be in stage B2 and boys in G2-G3 with measurable oestradiol and testosterone levels respectively Inclusion criteria - pre-pubertal patients: 1. Girls and boys with high probability of transsexualism according to psychologist or psychiatrist and the age of 9 to 12 years 2. Girls have to be in an earlier stage than B2 and boys in an earlier stage than G2-G3 Inclusion criteria - healthy subjects: 1. Girls and boys who are similar aged friends of the transsexual patients

Exclusion criteria

Exclusion criteria: Exclusion criteria - patients: 1. Intersex conditions Exclusion criteria - healthy subjects: 1. Puberty delaying treatment or hormonal therapy; oral anticonception users are not excluded

Design outcomes

Primary

MeasureTime frame
1. Cognition: performance and reaction time on three cognition tasks (verbal fluency task, mental rotation task and emotional faces task), reaction times and performance will be measured 2. Functional MRI: data during the verbal fluency task, mental rotation task and emotional faces task 3. Structural MRI: data on total brain volume, grey and white matter (amount and percentage), Cerebrospinal Fluid (CSF), volume frontal and temporal lobe, gyrification, brain asymmetry. ROI analysis of basal ganglia, amygdala, hippocampus, corpus callosum, hypothalamus The timepoints at which the primary and secondary outcomes are measured for the patients are: 1. Prepubertal stage 2. Before start of GnRH analogue Triptoreline/Decapeptyl-CR (current puberty delaying medication for transsexual adolescents in the VUmc from the age of 12 and if puberty has already started, i.e., Tanner stage B2 in girls, G1-2 in boys) 3. Before start of cross-sex hormones (17-beta oestradiol in male-to-female transsexuals and sustanon in female-to-male transsexuals) 4. One year after start of cross-sex hormones 5. One to two years after gender reassignment surgery The timepoints for the control subjects are related to the time points of the patients, for they are age-matched friends of the patients. These timepoints are: 1. The moment that the transsexual friend starts with puberty delaying treatment 2. The moment that the transsexual friend starts with cross-sex hormones 3. One to two years after surgery of the transsexual friend

Secondary

MeasureTime frame
1. Score from -10 to 10 on handedness questionnaire 2. Performance score on adapted Wechsler Intelligence Scale for Children-III (WISC-III) questionnaire (four items: two performance, two verbal) 3. Information about psychological functioning (parent questionnaire) 4. Anthropometric data, information about pubertal stage according to Tanner 5. Information about homosexuality/transsexuality in family members 6. Digital photographs and physical appearance list (14 items) The timepoints at which the primary and secondary outcomes are measured for the patients are: 1. Prepubertal stage 2. Before start of GnRH analogue Triptoreline/Decapeptyl-CR (current puberty delaying medication for transsexual adolescents in the VUmc from the age of 12 and if puberty has already started, i.e., Tanner stage B2 in girls, G1-2 in boys) 3. Before start of cross-sex hormones (17-beta oestradiol in male-to-female transsexuals and sustanon in female-to-male transsexuals) 4. One year after start of cross-sex hormones 5. One to two years after gender reassignment surgery The timepoints for the control subjects are related to the time points of the patients, for they are age-matched friends of the patients. These timepoints are: 1. The moment that the transsexual friend starts with puberty delaying treatment 2. The moment that the transsexual friend starts with cross-sex hormones 3. One to two years after surgery of the transsexual friend

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026