Clinical trial NCT04309760: Developmental Correlates and Hormone Therapy Effects in Gender Dysphoria
Official title: Developmental Correlates and Hormone Therapy Effects in Gender Dysphoria
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gender Dysphoria
Keywords: gender dysphoria
neuroimaging
hormone-surgical reassignment
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between Mtf and control subjects.
Primary purpose: OTHER

Brief summary: The aim of the research is to study longitudinally the effects of reassignment hormonotherapy on the connectome of MtF (biological men who are transitioning to the female gender) dysphoric subjects after 6 months of hormone therapy. The subjects will be compared to a control group of healthy subjects taking into account sexual orientation

Detailed description: The pathophysiology of gender dysphoria is still poorly understood, but a number of clues point to an origin derived from biological and environmental factors, particularly studies of twins, birth order, and family groups. Several explanatory models have been put forward. In particular, the differentiation of genitals taking place in the first half of pregnancy while that of the brain in the second makes it possible to imagine a different differentiation between the external phenotype and the cerebral gender. Several developmental features have thus been found in gender dysphoric subjects, including the finger length ratio D2 / D4, lateralization. Some neuroimaging studies have shown brain features in gender dysphoric subjects that seem original compared to control subjects. Nevertheless, the results are scarce, poorly reproduced, and for some, the differences highlighted may be related to phenotypic variability including the non-consideration of sexual orientation. Moreover, some of these studies combine subjects treated or not with hormone therapy which is a bias because it is likely that hormone therapy may have structural and functional effects on brain function. The investigators team deals with dysphoric gender issues as part of a coordinated course of hormone-surgical reassignment. We wish to better characterize the brain effects, at the level of the "connectome" of the reassignment hormone therapy in a population of dysphoric subjects, taking into account signs of pre-natal hormonal impregnation (D2 / D4 ratio), developmental features (onset of dysphoria, lateralization, size), and controlling sexual orientation as a potential confounding factor.

The aim of the research is then to study longitudinally the effects of reassignment hormonotherapy on the connectome of MtF dysphoric subjects after 6 months of hormone therapy. The subjects will be compared to a control group of healthy subjects taking into account sexual orientation.

This is a prospective longitudinal study that includes, in a consecutive manner, open-label patients with MtF gender dysphoria (biological men who are transitioning to the female gender) attending the forensic psychiatric consultation for a request for hormone-surgical reassignment. Subjects will receive initial clinical assessment and MRI before and 6 months after initiation of hormone therapy; the imaging data will be compared to a control group (n = 20).

Eligibility criteria: Inclusion Criteria:

* gender dysphoric subjects MtF
* right handed
* androphilic orientation
* without hormone therapy

Control group of male subjects:

* right handed
* without any psychiatric or medical history
* androphilic orientation

Exclusion Criteria:

* MRI contraindication
* vulnerable adults
* mental retardation
* psychiatric or neurological disease including autism spectrum disorders, psychotropic medication
* hormonal or genetic condition

Primary outcomes:
measure: Brain connectome 6 months after the hormone therapy beginning
timeFrame: 6 months after the beginning of the hormone therapy
Secondary outcomes:
measure: Brain connectome in gender dysphoric and control subjects
timeFrame: baseline
measure: Gender dysphoria phenotype description
timeFrame: baseline and 6 months after the beginning of the hormone therapy
measure: Brain connectome variations
timeFrame: 6 months after the beginning of the hormone therapy
Other outcomes:
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