An observational study in Polycystic Ovary Syndrome, sponsored by Hospital Clinic of Barcelona. Status unknown at 1 site in Spain. Open to female participants aged 16 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by Hospital Clinic of Barcelona · Observational
A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.
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.
The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A)
PCOS patients without gestational desire who met the following criteria
Exclusion Criteria:
The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A) which include the presence of oligo-anovulation (cycles lasting \>35 days or amenorrhea) and hyperandrogenemia /hyperandrogenism (hirsutism or obvious acne or pronounced alopecia). All patients should have bilateral polycystic ovaries morphology on ultrasound. Additionally, the authors have decided to enroll PCOS patients that are all without pregnancy desire at the moment they fill out the questionnaires, in order to control for the potential confounding role of infertility on psychological outcomes. Different pituitary, adrenal, ovarian, thyroid or metabolic diseases will be excluded
Diagnostic Test: SF-36 (Short Form Health Survey)
The authors will enroll a control group of 30 women, age- matched with the PCOS women, from consecutive women controlled in the same outpatient clinic who met the following inclusion criteria: history of irregular menstrual cycle in absence of severe gynecologic and non-gynecologic diseases. This PCOS sample will be entirely constituted by women with no pregnancy desire; therefore, with the aim to limit the potential effect of the unfulfilled wish to conceive in the final results; additionally, infertile women will not admitted into the control group.
Diagnostic Test: SF-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.
Also known as: Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory
Quality of Life
results of SF-36
Time frame: january 9th 2018-january 9th 2019
Sexuality
Results of FSFI
Time frame: january 9th 2018-january 9th 2019
Psychological distress
Results of Symptom Checklist-90-Revision (SCL-90-R)
Time frame: january 9th 2018-january 9th 2019
Anger and aggressiveness
results of State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2)
Time frame: january 9th 2018-january 9th 2019
Biochemical markers
Results of blood tests including biochemistry and hormones analysis
Time frame: january 9th 2018-january 9th 2019
Phenotipical traits
Record of hirsutism, acne, alopecia, and other hyperandrogenic symptoms
Time frame: january 9th 2018-january 9th 2019
Plan to share: No
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Hospital Clinic of Barcelona