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

Not yet recruiting

• Conditions: Polycystic Ovarian Syndrome (PCOS)

• Registration Number: NCT06887296
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Study Start: 2026-06
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of Sexual Function and Distress in Women with Polycystic Ovary Syndrome Using BISF-W Scores	Day 1	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.
Evaluation of Sexual Function and Distress in Women with Polycystic Ovary Syndrome Using FSDS-R Scores	Day 1	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

Secondary Outcome Measures

Name	Time	Method
Assessment of Body Image Satisfaction Using the QIC Questionnaire	Day 1	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
Evaluation of Anxiety and Depression Using the HADS Scale	Day 1	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.

Trial Locations

Locations (1)

CHU Paule de Viguier; 🇫🇷 Toulouse, France