Gender Dysphoria, AdultTRANSIDENTNCT04935164
Comparative Study of Gender Identity Disorder Versus Control
An observational study of Gender Dysphoria, Adult, run by Centre Hospitalier Henri Laborit at 1 site in France.
Trial summary
Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria, Adult
- What is being tested?
- Psychiatric evaluations
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2021to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Contact sponsor for more details
Who may be able to join
- Patients with gender dysphoria
- Without psychotropic
- Without hormono-therapy
- Without sexual surgery assignation
Who cannot join
- Any depression
- Any addiction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Henri Laborit
Poitiers, 86021
Bérangère Thirioux, PhD, berangere.thirioux@ch-poitiers.fr
About this study
Official title: Comparative Study of Gender Dysphoria Phenomenology and Neurophysiology: Clinical and Experimental Exploration of Gender Identity Disorder
Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity.
Read the detailed description
Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity. Gender dysphoria is accompanied by the often overwhelming need for a hormonal or even hormone-surgical transition. Gender dysphoria is very often characterized by fluctuating mood sadness, irritability, obsessionality. An improvement in the quality of life after medical treatment (hormone therapy) and gender reassignment surgery has been described in the literature. Morphological similarities have been found between the brains of women and the brains of so-called transgender women, as well as between the brains of transgender men and men. These morphological data are only very fragmentary and have not been supported by neuro-functional data. Self-awareness, which refers to the awareness that an individual has of his body, his image and his own identity, is partly underpinned, at the brain level, by the activation of the Default Mode Network (DMN) at rest, in non-pathological conditions. The conflict between the internal perception of the own body and its objective representation could result in a change in brain connectivity within the DMN, due in particular to changes in the activation of the temporo parietal junction.
- Conditions
- Gender Dysphoria, Adult
- Being tested
- Psychiatric evaluations
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric evaluationsOther
Also called Electroencephalography, Double Mirror Test, Mini International Neuropsychiatric Interview, Montgomery-Åsberg Depression Rating Scale
At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes
| Study group | Role | What they receive |
|---|---|---|
| Male patients with gender dysphoria | * male patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation
* patients without psychotropic treatments
* patients who do not benefit of hormone therapy
* patients who have not yet received gender reassignment surgery
* patients aged 18 to 60 years
* patients with normal or corrected vision
* patients without mental defect
* patients without neurological impairment Receives: Other: Psychiatric evaluations | |
| Female patients with gender dysphoria | * female patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation
* patients without psychotropic treatments
* patients who do not benefit of hormone therapy
* patients who have not yet received gender reassignment surgery
* patients aged 18 to 60 years
* patients with normal or corrected vision
* patients without mental defect
* patients without neurological impairment Receives: Other: Psychiatric evaluations | |
| Male volunteers without gender dysphoria | * male volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation
* volunteer aged 18 to 60 years
* volunteer with normal or corrected vision
* volunteer without mental defect
* volunteer without neurological impairment Receives: Other: Psychiatric evaluations | |
| Female volunteers without gender dysphoria | * female volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation
* volunteer aged 18 to 60 years
* volunteer with normal or corrected vision
* volunteer without mental defect
* volunteer without neurological impairment Receives: Other: Psychiatric evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contribution of temporal parameters of microstates C, D, E and F
The proportion of the total time spent in microstates of class C,D,E and F
Measured: Week 1 to Week 24
Duration of temporal parameters of microstates C, D, E and F
Measured: Week 1 to Week 24
Mean-Global Field Power temporal parameters of microstates C, D, E and F
Measured: Week 1 to Week 24
Occurrence of temporal parameters of microstates C, D, E and F
Measured: Week 1 to Week 24
Cortical voxel activity from source reconstruction analysis, using electroencephalogram during Double Mirror Test (D.M.T).
Measured: Week 1 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start26 Mar 2021
- Primary completionMar 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender Dysphoria, AdultStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935164
- Sponsor's protocol ID
- 2020-A03407-32
- Acronym
- TRANSIDENT
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2021
- Last updated
- 23 Oct 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Gender Dysphoria Phenomenology and Neurophysiology: Clinical and Experimental Exploration of Gender Identity Disorder
- ClinicalTrials.gov ID
- NCT04935164
- Acronym / sponsor ID
- TRANSIDENT / 2020-A03407-32
- Conditions
- Gender Dysphoria, Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Jun 2021 (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.
Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity.
Detailed description
Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity. Gender dysphoria is accompanied by the often overwhelming need for a hormonal or even hormone-surgical transition. Gender dysphoria is very often characterized by fluctuating mood sadness, irritability, obsessionality. An improvement in the quality of life after medical treatment (hormone therapy) and gender reassignment surgery has been described in the literature. Morphological similarities have been found between the brains of women and the brains of so-called transgender women, as well as between the brains of transgender men and men. These morphological data are only very fragmentary and have not been supported by neuro-functional data. Self-awareness, which refers to the awareness that an individual has of his body, his image and his own identity, is partly underpinned, at the brain level, by the activation of the Default Mode Network (DMN) at rest, in non-pathological conditions. The conflict between the internal perception of the own body and its objective representation could result in a change in brain connectivity within the DMN, due in particular to changes in the activation of the temporo parietal junction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Male patients with gender dysphoria | – | Other: Psychiatric evaluations* male patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation * patients without psychotropic treatments * patients who do not benefit of hormone therapy * patients who have not yet received gender reassignment surgery * patients aged 18 to 60 years * patients with normal or corrected vision * patients without mental defect * patients without neurological impairment |
| Female patients with gender dysphoria | – | Other: Psychiatric evaluations* female patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation * patients without psychotropic treatments * patients who do not benefit of hormone therapy * patients who have not yet received gender reassignment surgery * patients aged 18 to 60 years * patients with normal or corrected vision * patients without mental defect * patients without neurological impairment |
| Male volunteers without gender dysphoria | – | Other: Psychiatric evaluations* male volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation * volunteer aged 18 to 60 years * volunteer with normal or corrected vision * volunteer without mental defect * volunteer without neurological impairment |
| Female volunteers without gender dysphoria | – | Other: Psychiatric evaluations* female volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation * volunteer aged 18 to 60 years * volunteer with normal or corrected vision * volunteer without mental defect * volunteer without neurological impairment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Contact sponsor for more details
Key inclusion criteria (4 listed)
- Patients with gender dysphoria
- Without psychotropic
- Without hormono-therapy
- Without sexual surgery assignation
Key exclusion criteria (2 listed)
- Any depression
- Any addiction
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 |
|---|---|---|
| Psychiatric evaluationsAlso: Electroencephalography, Double Mirror Test, Mini International Neuropsychiatric Interview, Montgomery-Åsberg Depression Rating ScaleAt different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes | Other | Female patients with gender dysphoria, Female volunteers without gender dysphoria, Male patients with gender dysphoria, Male volunteers without gender dysphoria |
Primary outcome
Contribution of temporal parameters of microstates C, D, E and F
Time frame: Week 1 to Week 24
The proportion of the total time spent in microstates of class C,D,E and F
Duration of temporal parameters of microstates C, D, E and F
Time frame: Week 1 to Week 24
Mean-Global Field Power temporal parameters of microstates C, D, E and F
Time frame: Week 1 to Week 24
Occurrence of temporal parameters of microstates C, D, E and F
Time frame: Week 1 to Week 24
Cortical voxel activity from source reconstruction analysis, using electroencephalogram during Double Mirror Test (D.M.T).
Time frame: Week 1 to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, Adult, run by Centre Hospitalier Henri Laborit at 1 site in France.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bérangère Thirioux, PhD (0033 5 49 44 58 56, berangere.thirioux@ch-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contribution of temporal parameters of microstates C, D, E and F (time frame: Week 1 to Week 24). The study lists 5 primary outcomes in all. 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 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.