Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.

Detailed Description
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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.

Official Title
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Hospital Clínic Barcelona

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Diagnostic Test: SF-36 (Short Form Health Survey)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1/PCOS<br>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)<br>* 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.<br>* Other names: Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory;|
| 2/CONTROL<br>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)<br>* 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.<br>* Other names: Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | results of SF-36 | january 9th 2018-january 9th 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexuality | Results of FSFI | january 9th 2018-january 9th 2019 | 
| Psychological distress | Results of Symptom Checklist-90-Revision (SCL-90-R) | january 9th 2018-january 9th 2019 | 
| Anger and aggressiveness | results of State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2) | january 9th 2018-january 9th 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexuality, PCOS, Quality of life, Psychological traits