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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR868
• Date of registration: 10/01/2007
• Primary sponsor: VU University Medical Center, Department of Pediatrics
• Public title: Brain development, brain functioning, growth and metabolic aspects in the clinical management of transsexual adolescents.
• Scientific title: Brain development, brain functioning, growth and metabolic aspects in the clinical management of transsexual adolescents. - clinical study on transsexual adolescents
• Date of first enrolment: 1/2/2007
• Target sample size: 264
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=868
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: [default]

Countries of recruitment

The Netherlands

Contacts

• Name: F.M. Wouters

• Name: F.M. Wouters

Key inclusion & exclusion 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 estradiol 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 9-12 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 patients:

1. Intersex conditions;




Exclusion criteria healthy subjects:

1. Puberty delaying treatment or hormonal therapy; oral anticonception users are not excluded.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Brain development, Transsexualism, DSM IV criteria

Intervention(s)

Patients: measurements will be performed at a prepubertal stage, 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), before start of cross-sex hormones (17 beta oestradiol in male-to-female transsexuals and sustanon in female-to-male transsexuals), one year after start of cross-sex hormones and 1-2 years after gender reassignment surgery.



Age matched control subjects (friends of the transsexual patients): measurements will be performed if the transsexual friend starts with puberty delaying treatment, if the transsexual friend starts with cross-sex hormones and 1-2 years after surgery of the transsexual friend.




Interventions:

1. Structural MRI, method used: voxel based morphometry, ROI analysis;

2. Functional MRI (BOLD) during which 3 cognition tasks will be performed (mental rotation, verbal fluency and emotional faces);

3. Physical examination with anthropometric measurements and gathering of information about pubertal stage according to Tanner;

4. Digital photographs and physical appearance list;

5. Salivary testosterone measurements;

6. Family pedigree research: homosexuality/ transsexuality in family.




The duration of the intervention will be approximately three hours for every visit, which means at maximum 5 visits (if patients will be followed longitudinally) for the patients and three visits (if control subjects will be followed longitudinally) for the control subjects.

Primary Outcome(s)

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, gray and white matter (amount and percentage), CSF, volume frontal and temporal lobe, gyrification, brain asymmetry. ROI analysis of basal ganglia, amygdala, hippocampus, corpus callosum, hypothalamus.

Secondary Outcome(s)

1. Score from -10 to 10 on handedness questionairre;

2. Performance score on adapted WISC-III questionairre (4 items: 2 performance, 2 verbal);

3. Information about psychological functioning (parent questionairre);

4. Anthropometric data, information about pubertal stage according to Tanner;

5. Information about homosexuality/ transsexuality in familymembers;

6. Digital photographs and physical appearance list (14 items).

Secondary ID(s)

ISRCTN81574253

Source(s) of Monetary Support

Ferring Pharmaceuticals Denmark

Secondary Sponsor(s)

VU University Medical Center, Department of Medical Psychology

VU University Medical Center, Department of Pediatric Endocrinology