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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB : 2025-A00613-46 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with polycystic ovary syndrome |
| ||
| Women without polycystic ovary syndrome |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| women answer a questionnaire | Other | Sexual Function and Distress Assessment in Women with Polycystic Ovary Syndrome (PCOS) Using Standardized Questionnaires |
|
| 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 |
| 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 |
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Inclusion Criteria:
For patients in the test group (PCOS):
For patients in the control group:
Exclusion Criteria:
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The study population consists of women with or without polycystic ovary syndrome to constitute 2 groups of 40 participants.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Gosset | University Hospital of Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Paule de Viguier | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| 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 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |