DSD-Life: Clinical European study on the outcome of surgical and hormonal therapy and psychological intervention in disorders of sex development (DSD)

Completed

Conditions: intersekse
intersex
10014699
10010612

Registration Number: NL-OMON38614

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 205

Inclusion Criteria

Individuals with sex chromosome, XY DSD and XX DSD >= 16 years. Patients with psychiatric disorder will not be excluded. Their medical records are required
Probands >= 16 -<18 years will be included as pubertal development is largely completed in this period. Complete pubertal development is mandatory to evaluate psychosexual development.

Exclusion Criteria

Individuals without the mental capability to answer the questionnaires themselves
Simultaneous participation in other studies investigating drugs or hormones.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameter(s)<br /><br>Health status, health related quality of life, psychological and social<br /><br>well-being, gender dysphoria, experiences and satisfaction with sexuality.<br /><br><br /><br>Primary endpoints: Identification of factors influencing psychosocial<br /><br>adaptation including, HRQoL and social - and psychological well-being, which<br /><br>can be improved in future clinical care.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameter(s)<br /><br>Sex assignment, genital surgery, hormone therapy, metabolism, fertility,<br /><br>psychosocial care, satisfaction with health care, psychosexual development, and<br /><br>hormone treatment.<br /><br><br /><br>Secondary endpoints: Identification of factors affecting metabolism, fertility,<br /><br>surgical outcome and psychosexual development, which can be changed in future<br /><br>clinical care.</p><br>