Assessment of the Impact of Polycystic Ovary Syndrome on Women's Sexuality (SexOPK)

This study, titled SexOPK, aims to evaluate the impact of polycystic ovary syndrome (PCOS) on women's sexual health. PCOS is a common endocrine disorder affecting 5-20% of women of reproductive age, often leading to hormonal imbalances, metabolic issues, and psychological distress. Despite existing studies on the subject, the level of sexual distress associated with PCOS-related sexual dysfunction remains unclear.

The study will compare sexual function and distress levels between women diagnosed with PCOS and a control group without PCOS. Participants will complete an online questionnaire assessing various aspects of sexual health, body image, anxiety, and depression. The findings may help healthcare professionals better understand and address sexual dysfunction in women with PCOS.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovarian Syndrome (PCOS)
• Intervention / Treatment: Other: women answer a questionnaire

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • CHU Paule de Viguier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women with or without polycystic ovary syndrome to constitute 2 groups of 40 participants.

Description

Inclusion Criteria:

For patients in the test group (PCOS):

• Adults
• Carriers of medically diagnosed polycystic ovarian syndrome
• Non-opposition

For patients in the control group:

• Adults
• Not carriers of polycystic ovarian syndrome
• Unopposed

Exclusion Criteria:

• Patient under court protection, guardianship, or curatorship
• Does not understand or speak French

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with polycystic ovary syndrome	Other: women answer a questionnaire; Sexual Function and Distress Assessment in Women with Polycystic Ovary Syndrome (PCOS) Using Standardized Questionnaires
Women without polycystic ovary syndrome	Other: women answer a questionnaire; Sexual Function and Distress Assessment in Women with Polycystic Ovary Syndrome (PCOS) Using Standardized Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Sexual Function and Distress in Women with Polycystic Ovary Syndrome Using BISF-W Scores	The Brief Index of Sexual Functioning for Women (BISF-W) is a validated questionnaire that assesses various aspects of female sexual function, including desire, arousal, frequency of sexual activity, receptivity, orgasm, satisfaction, and concerns affecting sexuality. It consists of 22 items, generating a composite score that reflects overall sexual well-being. Higher BISF-W scores indicate better sexual function, while lower scores suggest sexual dysfunction or distress.	Day 1
Evaluation of Sexual Function and Distress in Women with Polycystic Ovary Syndrome Using FSDS-R Scores	The Female Sexual Distress Scale-Revised (FSDS-R) is a 13-item questionnaire designed to measure sexual distress in women, including feelings of frustration, guilt, stress, and dissatisfaction related to sexual activity. The total score ranges from 0 to 52, with higher scores indicating greater sexual distress and lower scores reflecting better emotional well-being regarding sexuality	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Body Image Satisfaction Using the QIC Questionnaire	The third part corresponds to the QIC questionnaire (Body Image Questionnaire), which includes 19 items and explores body satisfaction/dissatisfaction indirectly, by taking into account a set of desirable/undesirable bodily attributes and states	Day 1
Evaluation of Anxiety and Depression Using the HADS Scale	The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire designed to assess anxiety and depression symptoms in non-psychiatric medical settings. It consists of two subscales: HADS-A (7 items for anxiety) and HADS-D (7 items for depression). Each item is scored from 0 to 3, leading to subscale scores ranging from 0 to 21 and a total score from 0 to 42. For each subscale, a lower score (0-7) indicates normal emotional status, 8-10 suggests a borderline case, and 11-21 reflects clinically significant anxiety or depression. A higher total score indicates greater psychological distress, while a lower score reflects better mental well-being.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Anna Gosset, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Actual): October 24, 2025
• Study Completion (Actual): October 24, 2025

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Polycystic Ovary Syndrome; Sexual Health; Female Sexuality
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome
• Other Study ID Numbers: RC31/25/0135; ID-RCB : 2025-A00613-46 (Other Identifier: ANSM)

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
• product manufactured in and exported from the U.S.: No