Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome
NCT ID: NCT03306459
Last Updated: 2017-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2018-01-09
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1/PCOS
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
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.
2/CONTROL
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
16 Years
50 Years
FEMALE
Yes
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Camil Castelo-Branco
Professor
Principal Investigators
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Camil Castelo-Branco, MD PhD
Role: STUDY_DIRECTOR
Hospital Clínic. University of Barcelona
Locations
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Hospital Clínic
Barcelona, , Spain
Countries
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Central Contacts
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Camil Castelo-Branco
Role: CONTACT
Facility Contacts
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Camil Castelo-Branco, MD PhD
Role: primary
References
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Naumova I, Castelo-Branco C, Casals G. Psychological Issues and Sexual Function in Women with Different Infertility Causes: Focus on Polycystic Ovary Syndrome. Reprod Sci. 2021 Oct;28(10):2830-2838. doi: 10.1007/s43032-021-00546-x. Epub 2021 Mar 24.
Other Identifiers
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B/2017/0614
Identifier Type: -
Identifier Source: org_study_id