Polycystic Ovarian Syndrome (PCOS)SexOPKNCT06887296
Assessment of the Impact of Polycystic Ovary Syndrome on Women's Sexuality
An observational study of Polycystic Ovarian Syndrome (PCOS), run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- women answer a questionnaire
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2025to 24 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of women with or without polycystic ovary syndrome to constitute 2 groups of 40 participants.
Who may be able to join
- 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
Who cannot join
- Patient under court protection, guardianship, or curatorship
- Does not understand or speak French
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Being tested
- women answer a questionnaire
- Keywords
- Polycystic Ovary Syndrome, Female Sexuality, Quality of Life, Sexual Health
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
women answer a questionnaireOther
Sexual Function and Distress Assessment in Women with Polycystic Ovary Syndrome (PCOS) Using Standardized Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Women with polycystic ovary syndrome | Not described Receives: Other: women answer a questionnaire | |
| Women without polycystic ovary syndrome | Not described Receives: Other: women answer a questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Day 1
Secondary outcomes (2)
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
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start30 Jun 2025
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Gosset, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887296
- Sponsor's protocol ID
- RC31/25/0135
- Other IDs
- ID-RCB : 2025-A00613-46
- Acronym
- SexOPK
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Polycystic Ovary Syndrome on Women's Sexuality
- ClinicalTrials.gov ID
- NCT06887296
- Acronym / sponsor ID
- SexOPK / RC31/25/0135
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- Polycystic Ovary Syndrome, Female Sexuality, Quality of Life, Sexual Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with polycystic ovary syndrome | – | Other: women answer a questionnaire |
| Women without polycystic ovary syndrome | – | Other: women answer a questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of women with or without polycystic ovary syndrome to constitute 2 groups of 40 participants.
Key inclusion criteria (8 listed)
- Adults
- Carriers of medically diagnosed polycystic ovarian syndrome
- Non-opposition
- Adults
- Not carriers of polycystic ovarian syndrome
Key exclusion criteria (2 listed)
- Patient under court protection, guardianship, or curatorship
- Does not understand or speak French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| women answer a questionnaireSexual Function and Distress Assessment in Women with Polycystic Ovary Syndrome (PCOS) Using Standardized Questionnaires | Other | Women with polycystic ovary syndrome, Women without polycystic ovary syndrome |
Primary outcome
Evaluation of Sexual Function and Distress in Women with Polycystic Ovary Syndrome Using BISF-W Scores
Time frame: 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
Time frame: 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
2 secondary outcomes
Assessment of Body Image Satisfaction Using the QIC Questionnaire
Time frame: Day 1
Evaluation of Anxiety and Depression Using the HADS Scale
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Gosset principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovarian Syndrome (PCOS), run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Sexual Function and Distress in Women with Polycystic Ovary Syndrome Using BISF-W Scores (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.