The present study will focus on the consequences of long-term delay of puberty induced by treatment with Decapeptyl-CR. We will investigate the effects of this treatment in regard to brain functioning, brain development, various endocrine, metabolic…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Cognition: performance and reaction time on three cognition tasks (verbal
fluency task, mental rotation task and emotional faces task)
* Functional MRI: data during the verbal fluency task, mental rotation task and
emotional faces task.
* 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
* score from -10 to 10 on handedness questionairre
* performance score on adapted WISC-III questionairre (4 items: 2 performance,
2 verbal)
* information about psychological functioning (parent questionairre)
* anthropometric data, information about pubertal stage according to Tanner
* information about homosexuality/ transsexuality in familymembers
* digital photographs and physical appearance list (14 items)
Background summary
The clinical management of transsexual adolescents of the VUmc consists of
suppression of puberty with GnRH analogues from the moment the juvenile
transsexuals reach pubertal stage 2 according to Tanner. From the age of 16
they receive cross-sex hormones in addition to the puberty delaying medication.
Treatment at this age and the use of GnRH agonists as a diagnostic aid is still
controversial. Knowing more about the effect of hormone treatment is not only
of theoretical interest but also of very great clinical relevance. The
hypothesis of this study is that brain functioning and brain structure of
transsexual teenagers treated with GnRH agonists is according healthy
individuals without transsexuality.
Little is known about etiological aspects of transsexuality. Transsexuality is
associated with atypical sex hormone levels during pregnancy. The hypothesis is
that in transsexualism the development of brain structures and brain
functioning is in the direction of the desired sex instead of the biological
sex.
The VUmc gender team for children and adolescents assesses early-onset
transsexuals on a regular basis. This group is unique since, according to their
parents, these transsexual children and adolescents did never show gender
related behaviour corresponding with their biological sex, neither did they use
cross-sex hormones, which might be influential on their brain development. We
therefore believe that the best chances to find biological differences in brain
development and function between transsexuals and non-transsexual are in this
group. As the VUmc assesses by far the largest number of transsexual
adolescents in the world, we are in a unique position to generate findings that
may give us insight in the aetiology of the phenomenon and the effects of these
pituary agonists on brain development
Study objective
The present study will focus on the consequences of long-term delay of puberty
induced by treatment with Decapeptyl-CR. We will investigate the effects of
this treatment in regard to brain functioning, brain development, various
endocrine, metabolic and anthropometric aspects before, during and after
treatment with Decapeptyl-CR alone and in combination with cross-sex hormones
in juvenile transsexuals. Hereby we will focus on sex differences between
transsexual adolescents and similar aged individuals of both sexes by
investigating brain development and brain functioning, as well as on possible
determinants of the aetiology of transsexuality by means of structural and
functional MRI and family pedigree research.
Study design
This study is an observational, non invasive cross-sectional (with longitudinal
continuation) prospective follow-up study.
Study burden and risks
There are no risks.
We use MR imaging, which is a non-invasive technique, there is no potential
harm from radiation. We measure salivary testosterone instead of blood samples
which is less invasive. All investigations will take place on the same day to
minimize the effort for the subjects. We practise the cognition tasks in
advance to reduce the stress of the subjects during scanning. We provide video,
audio and photo material and s dummy scanner will be available to prepare the
subjects for the MRI-scanner. If the extend of the burden is too much, the
scanning will not be continued.
boelelaan 1117
1081 HV
NL
boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria pubertal patients: 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) . Girls have to be in stage B2 and boys in G2-G3 with measurable estradiol and testosterone levels respectively.
Inclusion criteria pre-pubertal patients: girls and boys with high probability of transsexualism according to psychologist or psychiatrist and the age of 9-12 years. Girls have to be in an earlier stage than B2 and boys in an earlier stage than G2-G3.
Inclusion criteria healthy subjects: girls and boys who are similar aged friends of transsexual patients
Exclusion criteria
Exclusion criteria patients: intersex conditions
Exclusion criteria healthy subjects: puberty delaying treatment or hormonal therapy, oral anticonception users are not excluded
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL15404.029.06 |