Gender DysphoriaDCHGDNCT04309760
Developmental Correlates and Hormone Therapy Effects in Gender Dysphoria
A study testing MRI in people with Gender Dysphoria, run by Hôpital le Vinatier.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- MRI contraindication
- vulnerable adults
- mental retardation
- psychiatric or neurological disease including autism spectrum disorders, psychotropic medication
- hormonal or genetic condition
About this study
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
Read the 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).
- Conditions
- Gender Dysphoria
- Being tested
- MRI
- Keywords
- gender dysphoria, neuroimaging, hormone-surgical reassignment
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Subjects will receive structural and functional (resting state) MRI
| Study group | Role | What they receive |
|---|---|---|
| gender dysphoria subjects | Active comparator | 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 Receives: Other: MRI |
| control subjects | Other | Control group inclusions, of open-label patients without gender dysphoria. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain connectome 6 months after the hormone therapy beginning
Structural and functional MRI before and after 6 months of hormone therapy will be analysed in order to make a comparison before/after
Measured: 6 months after the beginning of the hormone therapy
Secondary outcomes (3)
Brain connectome in gender dysphoric and control subjects
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.
Measured: baseline
Gender dysphoria phenotype description
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.
Measured: baseline and 6 months after the beginning of the hormone therapy
Brain connectome variations
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.
Measured: 6 months after the beginning of the hormone therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study startFeb 2021 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Mar 2022
Why it stopped: the patients are now followed in another hospital. The study is discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between Mtf and control subjects.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309760
- Sponsor's protocol ID
- 2019-A01997-50
- Acronym
- DCHGD
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2020
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Correlates and Hormone Therapy Effects in Gender Dysphoria
- ClinicalTrials.gov ID
- NCT04309760
- Acronym / sponsor ID
- DCHGD / 2019-A01997-50
- Conditions
- Gender Dysphoria
- Keywords
- gender dysphoria, neuroimaging, hormone-surgical reassignment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the patients are now followed in another hospital. The study is discontinued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison between Mtf and control subjects.
| Arm | Type | Receives |
|---|---|---|
| gender dysphoria subjects | Active comparator | Other: MRIPatients 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 |
| control subjects | Other | Other: MRIControl group inclusions, of open-label patients without gender dysphoria. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- gender dysphoric subjects MtF
- right handed
- androphilic orientation
- without hormone therapy
- right handed
Key exclusion criteria (5 listed)
- MRI contraindication
- vulnerable adults
- mental retardation
- psychiatric or neurological disease including autism spectrum disorders, psychotropic medication
- hormonal or genetic condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRISubjects will receive structural and functional (resting state) MRI | Other | control subjects, gender dysphoria subjects |
Primary outcome
Brain connectome 6 months after the hormone therapy beginning
Time frame: 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
3 secondary outcomes
Brain connectome in gender dysphoric and control subjects
Time frame: baseline
Gender dysphoria phenotype description
Time frame: baseline and 6 months after the beginning of the hormone therapy
Brain connectome variations
Time frame: 6 months after the beginning of the hormone therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Gender Dysphoria, run by Hôpital le Vinatier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain connectome 6 months after the hormone therapy beginning (time frame: 6 months after the beginning of the hormone therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.