Gynaecological Care for Transgender People in France in 2024. (GyneTrans)

April 25, 2024 updated by: University Hospital, Bordeaux
To date, the transgender population, still poorly characterized, tends to increase. The impact of gender-affirming hormone therapy (GAHT) in this population remains poorly understood, and few data are published on the gynecological repercussions of such therapy. A recent literature review by a French team suggests gynecological follow-up procedures for transgender people.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The hypothesis of this study is that transgender population in France does not have appropriate gynecological care, and the study would like to find out, directly from the people concerned, the current state of gynecological care for transgender people in France. To do this, ths study plan to send out a questionnaire to transgender people (via healthcare networks and also transgender associations) to ask them about their actual gynecological care and their knowledge of recommended gynecological care.

The aim is to set up a descriptive, declarative study based on a questionnaire created specifically for this work.

This project will use a questionnaire for transwomen people and another one for transmen people. Transgender people will be approached via Trans associations and healthcare networks. An online link to the questionnaire will be sent to trans associations and healthcare networks for distribution to the target population thanks to a flyer.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Transgender people (male and female) will be approached via Trans associations (face-to-face and online) and the care networks in place at national level.

An online link for completing the questionnaire will be sent to trans associations and healthcare networks for distribution to the target population via a paper or digital flyer.

Description

Inclusion Criteria:

  • French-speaking transgender person (transgender women or transgender men)
  • age ≥18 years

Exclusion Criteria:

  • age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transgender
Transgender population in France, male to female and female to male.
Other: Questionnaire
A flyer with QR code leading to the online questionnaire will be sent to trans associations and healthcare networks for distribution to the target population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of people aware of gynaecological recommendations.
Time Frame: 24 months after inclusion day
Percentage of transgender people who know regular gynaecological recommendations in France, thanks to a homemade questionnaire
24 months after inclusion day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of people aware of cancer risks
Time Frame: 24 months after inclusion day
Overview of organized screening for gynaecological cancers and prostate cancer in the transgender population, thanks to a homemade questionnaire
24 months after inclusion day
Percentage of people aware of contraception in transgender male population
Time Frame: 24 months after inclusion day
Overview of knowledge about contraception in the transgender male population,thanks to a homemade questionnaire.
24 months after inclusion day
Percentage of people aware of fertility and the impact of hormone treatments
Time Frame: 24 months after inclusion day
Overview of knowledge about fertility and the impact of hormone treatments in the transgender population, thanks to a homemade questionnaire.
24 months after inclusion day
Percentage of people aware of gynaecological repercussions of masculinizing hormone treatment in transgender male population
Time Frame: 24 months after inclusion day
Overview of our knowledge of the gynaecological repercussions of masculinizing hormone treatment in the transgender male population, thanks to a homemade questionnaire.
24 months after inclusion day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHUBX 2023/75

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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