DCHGD: Developmental Correlates and Hormone Therapy Effects in Gender Dysphoria

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04309760
Collaborator
(none)
0
2
13.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: MRI
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Comparison between Mtf and control subjects.Comparison between Mtf and control subjects.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Developmental Correlates and Hormone Therapy Effects in Gender Dysphoria
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Mar 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: gender dysphoria subjects

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

Other: MRI
Subjects will receive structural and functional (resting state) MRI

Other: control subjects

Control group inclusions, of open-label patients without gender dysphoria.

Other: MRI
Subjects will receive structural and functional (resting state) MRI

Outcome Measures

Primary Outcome Measures

  1. Brain connectome 6 months after the hormone therapy beginning [6 months after the beginning of the hormone therapy]

    Structural and functional MRI before and after 6 months of hormone therapy will be analysed in order to make a comparison before/after

Secondary Outcome Measures

  1. Brain connectome in gender dysphoric and control subjects [baseline]

    The 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.

  2. Gender dysphoria phenotype description [baseline and 6 months after the beginning of the hormone therapy]

    The 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.

  3. Brain connectome variations [6 months after the beginning of the hormone therapy]

    The 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hôpital le Vinatier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT04309760
Other Study ID Numbers:
  • 2019-A01997-50
First Posted:
Mar 16, 2020
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hôpital le Vinatier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022