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Developmental Correlates and Hormone Therapy Effects in Gender Dysphoria

Developmental Correlates and Hormone Therapy Effects in Gender Dysphoria

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04309760
Acronym
DCHGD
Enrollment
0
Registered
2020-03-16
Start date
2021-02-01
Completion date
2022-03-15
Last updated
2026-06-10

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

Conditions

Gender Dysphoria

Keywords

gender dysphoria, neuroimaging, hormone-surgical reassignment

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).

Interventions

OTHERMRI

Subjects will receive structural and functional (resting state) MRI

Sponsors

Hôpital le Vinatier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Comparison between Mtf and control subjects.

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Brain connectome 6 months after the hormone therapy beginning6 months after the beginning of the hormone therapyStructural and functional MRI before and after 6 months of hormone therapy will be analysed in order to make a comparison before/after

Secondary

MeasureTime frameDescription
Brain connectome in gender dysphoric and control subjectsbaselineThe MRI images will be analysed in order to construct a brain " connectome " which reflects brain connectivity, using the graph theory. At baseline, these networks will be compared between dysphoric and control subjects.
Gender dysphoria phenotype descriptionbaseline and 6 months after the beginning of the hormone therapyThe MRI images will be analysed in order to construct a brain " connectome " which reflects brain connectivity, using the graph theory. Correlations will be made at baseline between brain connectome of the dysphoric subjects and testosteronemia, and developmental measures : age at beginning of gender dysphoria, finger lenghth D2/D4 ratio, birth weight, laterality using Edimbourg scale.
Brain connectome variations6 months after the beginning of the hormone therapyThe MRI images will be analysed in order to construct a brain " connectome " which reflects brain connectivity, using the graph theory. Evolutions of the brain connectome of dysphoric subjects will be compared after 6 months of hormone therapy, taking into acount gender dysphoria decrease measured using Utrecht Gender Dysphoria Scale.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026