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

Hospital Clínic Barcelona

A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Diagnostic test: SF-36 (Short Form Health Survey)

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.; Other Names: Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory
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.	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.; Other Names: Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical markers	Results of blood tests including biochemistry and hormones analysis	january 9th 2018-january 9th 2019
Phenotipical traits	Record of hirsutism, acne, alopecia, and other hyperandrogenic symptoms	january 9th 2018-january 9th 2019

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Study Director: Camil Castelo-Branco, MD PhD, Hospital Clínic. University of Barcelona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 9, 2018
• Primary Completion (Anticipated): January 9, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Quality of life; PCOS; Sexuality; Psychological traits
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: B/2017/0614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No