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

NCT06887296 | Completed

• 2 other identifiers: RC31/25/0135ID-RCB : 2025-A00613-46
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Keywords

Polycystic Ovary Syndrome; Female Sexuality; Quality of Life; Sexual Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Assessment of Body Image Satisfaction Using the QIC Questionnaire

  Day 1

• Evaluation of Anxiety and Depression Using the HADS Scale

  Day 1

Study Arms (2)

Women with polycystic ovary syndrome

Other: women answer a questionnaire

Women without polycystic ovary syndrome

Other: women answer a questionnaire

Interventions

women answer a questionnaire OTHER

Sexual Function and Distress Assessment in Women with Polycystic Ovary Syndrome (PCOS) Using Standardized Questionnaires

Women with polycystic ovary syndrome; Women without polycystic ovary syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Paule de Viguier

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Anna Gosset

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: June 30, 2025
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)