Gender Incongruence, Transgender Individuals
Conditions
Keywords
Gender Affirming Hormone Therapy (GAHT), Gender Affirming Surgery (GAS), Transgender and Gender Diverse (TGD)
Brief summary
The goal of this observational study is to understand the factors influencing the well-being and health of transgender and gender-diverse (TGD) individuals undergoing gender-affirming therapies in Switzerland. The study population includes TGD individuals aged 16 and older, at various stages of their medical transition, including those who have discontinued or detransitioned. The main question is: What are the key factors influencing the well-being and health outcomes of transgender and gender-diverse individuals undergoing gender-affirming therapies? Researchers will compare health outcomes across different subgroups, such as those at different stages of transition or detransition, to examine the effects of gender-affirming therapies. Participants will: Complete electronic questionnaires assessing gender congruence, quality of life, mental health, and other outcomes. Provide biological samples (e.g., blood, urine, stool, and skin swabs) for laboratory analysis. Undergo clinical evaluations related to endocrinology, fertility, dermatology, and urology as part of their routine follow-up.
Interventions
OTHERGroup A (start of GAHT)
The study program consists of assessments at baseline (before the start of GAHT) and subsequent follow-up visits scheduled at routine intervals which are typically every three months for the first year, every six months for the second year and every twelve months thereafter. Participants' data collection includes a mix of digital and in-person methods. Demographical information, clinical and laboratory parameters such as hormone levels which are part of standard clinical care
OTHERGroup B (on-going GAHT)
The study program consists of a yearly assessment as part of the long-term routine follow-up. Participants' data collection includes a mix of digital and in-person methods. Demographical information, clinical and laboratory parameters such as hormone levels which are part of standard clinical care
OTHERGroup C (GAS)
If GAS is administered, additional assessments are performed preoperatively, and postoperatively in analogy with routine clinical visits, e.g. one week after surgery and then three, six and twelve months later (then once yearly) (e.g. type of surgery, outcome, patient' satisfaction). If participants undergo gender-affirming genital surgery, a genital swab and urine analysis (from the urine sample taken for routine testing) will additionally be performed for microbiome analyses as part of the study assessment.
Sponsors
University Hospital, Basel, Switzerland
University Hospital, Zürich
Cantonal Hospital Lucerne, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 16 years and above. * Established diagnosis of gender incongruence * Indication for gender affirming therapy or ongoing or discontinued gender affirming therapy
Exclusion criteria
* Unable to give informed consent * Missing commitment or ability to study protocol adherence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS) | Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months | The Gender Congruence and Life Satisfaction Scale (GCLS) is a validated outcome measure specifically developed for transgender individuals to assess distress and unhappiness with experienced gender and body, regardless of gender assigned at birth or gender identity. The scale ranges from \[insert range, e.g., 0-100\], with higher scores indicating greater gender congruence and life satisfaction, and lower scores reflecting greater distress and unhappiness. It is suitable for binary and nonbinary individuals seeking gender-affirming care. |
Countries
Switzerland
Contacts
CONTACTBettina Winzeler, PD Dr.
CONTACTHüseyin Cihan, Dr.
PRINCIPAL_INVESTIGATORBettina Winzeler, PD Dr.
University Hospital Basel, Department of Endocrinology
Outcome results
None listed