Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, Quality of life, Sexuality, Psychological traits
Brief summary
A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.
Detailed description
This project with PCOS patients include an assessment of quality of life and sexuality in naïve patients. Hypothesizing that PCOS women would show higher rates of psychological alterations, this study is aimed to investigate the association between polycystic ovary syndrome (PCOS) and psychological disturbances, including anger and to analyze whether the biochemical/phenotypical features of PCOS may play a role in the type and severity of psychological disorders.
Interventions
DIAGNOSTIC_TESTSF-36 (Short Form Health Survey)
Symptom Checklist-90-Revision (SCL-90-R): self-report questionnaire of 90 items on a 5-point Likert scale clustered in 9 primary scales (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism). State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2): self-report questionnaire of 57-items on a 4-point scale distributed in different dimensions: State-Anger, Trait-Anger Expression Anger (in-out) and Anger Control (in-out) Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. Female Sexual Function Index (FSFI) a 19-item self-report measure of female sexual function providing scores on 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) as well as a total score.
Sponsors
Hospital Clinic of Barcelona
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
PCOS patients without gestational desire who met the following criteria * Oligomenorrhea (cycles lasting \>35 days) or amenorrhea (no periods in 6 months) * Hyperandrogenemia/hyperandrogenism Hirsutism Ferriman-Gallwey score \> 12 Obvious acne or pronounced alopecia Androgen levels over normal female range
Exclusion criteria
* Prior psychiatric diagnosis * Current use of psychiatric medications * Difficulties with language comprehension in case of non-nationals. * Yatrogenic hirsutism, * Other endocrine deseases with hyperandrogenism or that may influence the final results Ovarian or adrenal neoplasia Prolactinoma Cushing's syndrome Congenital adrenal hyperplasia Diabetes mellitus Thromboembolic disease * Patients who had received any drug therapy for hirsutism over the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | january 9th 2018-january 9th 2019 | results of SF-36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexuality | january 9th 2018-january 9th 2019 | Results of FSFI |
| Psychological distress | january 9th 2018-january 9th 2019 | Results of Symptom Checklist-90-Revision (SCL-90-R) |
| Anger and aggressiveness | january 9th 2018-january 9th 2019 | results of State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biochemical markers | january 9th 2018-january 9th 2019 | Results of blood tests including biochemistry and hormones analysis |
| Phenotipical traits | january 9th 2018-january 9th 2019 | Record of hirsutism, acne, alopecia, and other hyperandrogenic symptoms |
Countries
Spain
Contacts
Primary ContactCamil Castelo-Branco, MD PhD
Backup ContactCamil Castelo-Branco
Outcome results
None listed