Gender DysphoriaNCT06098781
Gynaecological Gender-affirming Surgeries
An observational study of Gender Dysphoria, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomy, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gender Dysphoria
- How many people
- 57 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Sep 2022to 1 Jun 2025
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Trans-masculine or non-binary individuals (assigned female at birth) with wish to undergo gynaecological gender-affirming surgeries
Who may be able to join
- assigned female at birth
- scheduled to undergo gynaecological gender-affirming surgery (i.e. hysterectomy, ovariectomy, tubectomy and/or colpectomy)
Who cannot join
- age below 18 y/o
- surgery combined with other surgeries (e.g. urethroplasty, metoidioplasty)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, Location VU Medical Center
Amsterdam
Judith AF Huirn, MD, PhD, 020-5663654, secretariaat-vrouwenkliniek@amsterdamumc.nl
About this study
Official title: Patient Reported Outcomes After Gynaecological Gender Surgeries
The goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomy, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth).
The main question it aims to answer are:
- What is the experienced effect of gynaecological gender-affirming surgeries
Participants will be asked to fill out a questionaire pre-operatively and 3,9 and 18 months post-operatively.
- Conditions
- Gender Dysphoria
- Keywords
- hysterectomy, colpectomy, vaginectomy, tubectomy, patient-reported outcome measure
- Medical subject headings
- Gender Dysphoria
What is being measured
The primary outcome is the main question the study is designed to answer.
Experienced effect on gender dysphoria
On a scale of -5 to +5 the experienced effect on gender dysphoria
Measured: 3& 9 months
Experienced effect on gender dysphoria measured by GCLS
Comparison of GCLS score (gender congruence life satisfaction scale) pre-operatively and post-operatively
Measured: 9 & 18 months
Secondary outcomes (7)
Experienced effect on psychological well being
On a scale of -5 to +5 the experienced effect on psychological well being
Measured: 3 & 9 months
Experienced effect on confidence
On a scale of -5 to +5 the experienced effect on confidence
Measured: 3& 9 months
Experienced effect on sexual experience
On a scale of -5 to +5 the experienced effect on sexual experience
Measured: 3& 9 months
Surgical satisfaction
Measured: 3& 9 months
Impact of health on satisfaction of life
Comparison of Short Form Health Survey (SF12) pre- and postoperatively
Measured: 3 & 9 months
Physical complaints post-operatively
physical complaints (bleeding, discharge, abdominal/pelvic pain, difficulty sitting, difficulty peeing, climacterial other complaints)
Measured: 3 & 9 months
Recovery time postoperatively
Time to recovery of daily activities
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start2 Sep 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
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 Amsterdam UMC, location VUmcThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.A.F. Huirne, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098781
- Sponsor's protocol ID
- 2020.332
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2023
- Last updated
- 15 Nov 2023
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes After Gynaecological Gender Surgeries
- ClinicalTrials.gov ID
- NCT06098781
- Acronym / sponsor ID
- 2020.332
- Conditions
- Gender Dysphoria
- Keywords
- hysterectomy, colpectomy, vaginectomy, tubectomy, patient-reported outcome measure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 25 Oct 2023 (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 goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomy, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth).
The main question it aims to answer are:
- What is the experienced effect of gynaecological gender-affirming surgeries
Participants will be asked to fill out a questionaire pre-operatively and 3,9 and 18 months post-operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Trans-masculine or non-binary individuals (assigned female at birth) with wish to undergo gynaecological gender-affirming surgeries
Key inclusion criteria (2 listed)
- assigned female at birth
- scheduled to undergo gynaecological gender-affirming surgery (i.e. hysterectomy, ovariectomy, tubectomy and/or colpectomy)
Key exclusion criteria (2 listed)
- age below 18 y/o
- surgery combined with other surgeries (e.g. urethroplasty, metoidioplasty)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experienced effect on gender dysphoria
Time frame: 3& 9 months
On a scale of -5 to +5 the experienced effect on gender dysphoria
Experienced effect on gender dysphoria measured by GCLS
Time frame: 9 & 18 months
Comparison of GCLS score (gender congruence life satisfaction scale) pre-operatively and post-operatively
7 secondary outcomes
Experienced effect on psychological well being
Time frame: 3 & 9 months
Experienced effect on confidence
Time frame: 3& 9 months
Experienced effect on sexual experience
Time frame: 3& 9 months
Surgical satisfaction
Time frame: 3& 9 months
Impact of health on satisfaction of life
Time frame: 3 & 9 months
Physical complaints post-operatively
Time frame: 3 & 9 months
Recovery time postoperatively
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- 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.
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, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Nov 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith AF Huirne, MD, PhD (020-5663654, secretariaat-vrouwenkliniek@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experienced effect on gender dysphoria (time frame: 3& 9 months). The study lists 2 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 15 Nov 2023.