Polycystic Ovary SyndromeNCT07402980
Development of the Polycystic Ovary Syndrome Symptoms Inventory
An observational study of Polycystic Ovary Syndrome and Psychological Distress, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Polycystic Ovary Syndrome Symptom Severity and Distress Inventory: Development, Validity and Reliability in Turkey The goal of this observational study is to develop and validate a self-report inventory that assesses Polycystic Ovary Syndrome (PCOS) symptoms and the level of distress experienced by women diagnosed… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Psychological Distress
- How many people
- 227 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 15 Feb 2026
- 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 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consists of women aged 18-49 who have been diagnosed with Polycystic Ovary Syndrome (PCOS). The study aims to reach a sample size of at least 85 to 170 participants. Women who meet the inclusion criteria and agree to participate on a voluntary basis will be invited to the study. Data will be collected via an online survey form prepared by the researchers. Participants will be recruited through social media platforms (such as WhatsApp and Instagram). To ensure ethical standards, an informed consent text will be included at the beginning of the online form, and a mandatory question will be used to confirm voluntary participation. Additionally, a mandatory screening question regarding PCOS diagnosis will be included to verify that participants meet the inclusion criteria; individuals without a PCOS diagnosis will be excluded from the sample.
Who may be able to join
- Being a woman aged 18-49 (of reproductive age) who states she has been diagnosed with PCOS
- Being able to read and understand Turkish
- Volunteering to participate in the study
Who cannot join
- Having a disease that could cause symptoms similar to PCOS (such as Cushing's syndrome, thyroid dysfunction, hyperprolactinemia, androgen-secreting tumors)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University
Bolu, 14030
About this study
Official title: Polycystic Ovary Syndrome Symptoms Inventory: Development, Validity and Reliability in Turkey
Polycystic Ovary Syndrome Symptom Severity and Distress Inventory: Development, Validity and Reliability in Turkey
The goal of this observational study is to develop and validate a self-report inventory that assesses Polycystic Ovary Syndrome (PCOS) symptoms and the level of distress experienced by women diagnosed with PCOS. The main question it aims to answer is:
Read more
Is the newly developed inventory a valid and reliable instrument for assessing PCOS symptoms and related distress in women?
Participants will answer online survey questions including a demographic information form and three scales evaluating psychological health and PCOS related symptoms, including the newly developed symptom and distress inventory.
Read the detailed description
The research is a methodological scale development study.
A review of the literature reveals that despite strong evidence linking Polycystic Ovary Syndrome (PCOS) to anxiety, depression, and diminished quality of life, current assessment tools often fail to adequately represent psychological symptoms. There is a critical need for holistic and culturally sensitive instruments that address both the physical and psychological dimensions of PCOS. It is therefore thought that the developed scale will fill an important gap.
- Conditions
- Polycystic Ovary Syndrome, Psychological Distress
- Keywords
- Polycystic Ovary Syndrome, Symptom Burden, Psychological Distress, Inventory Development
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Women diagnosed with PCOS | Women aged 18-49 who report having been diagnosed with PCOS will be included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polycystic Ovary Syndrome Symptom Severity and Distress Inventory
The newly developed inventory consists of 34 items in total, with 17 items dedicated to evaluating PCOS symptom severity and 17 items for measuring distress levels. Each item is scored on a scale from 0 to 10. Total scores are calculated separately for symptom severity and distress levels, with each score ranging from 0 to 100. Higher scores on these measurements indicate an increase in both symptom severity and the level of distress experienced by the participant.
Measured: At the time of survey completion (Baseline)
Secondary outcomes (3)
Participant Information Form
A 10-item form developed by the researchers to collect sociodemographic data, such as age and educational background, as well as specific questions regarding the participants' Polycystic Ovary Syndrome (PCOS) history.
Measured: At the time of survey completion (Baseline)
Health-Related Quality of Life Questionnaire-50 for Polycystic Ovary Syndrome (PCOSQ-50)
This scale is designed to determine the impact of Polycystic Ovary Syndrome (PCOS) on quality of life. It consists of 50 items and 6 subscales: psychosocial and emotional, fertility, sexual function, obesity and menstrual disorders, hirsutism, and coping. Total scores range from 50 to 250. Subscale scores are determined by calculating the average score of the items answered within that specific domain. Unanswered items are excluded from the average score calculation.
Measured: At the time of survey completion (Baseline)
Kessler Psychological Distress Scale (K10-PDS)
This 10-item scale measures the frequency of symptoms such as nervousness, hopelessness, sadness, worthlessness, and fatigue to assess non-specific psychological distress. The scale is a 5-point Likert-type instrument, with total scores ranging from 10 to 50. Higher scores indicate higher levels of psychological distress.
Measured: At the time of survey completion (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Oct 2025
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Boğa, Abant Izzet Baysal University
- Investigators
- Melisa Bulut, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402980
- Sponsor's protocol ID
- AIBU-HEM-BB-01
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the confidentiality and privacy of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polycystic Ovary Syndrome Symptoms Inventory: Development, Validity and Reliability in Turkey
- ClinicalTrials.gov ID
- NCT07402980
- Acronym / sponsor ID
- AIBU-HEM-BB-01
- Conditions
- Polycystic Ovary Syndrome, Psychological Distress
- Keywords
- Polycystic Ovary Syndrome, Symptom Burden, Psychological Distress, Inventory Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 11 Feb 2026 (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.
Polycystic Ovary Syndrome Symptom Severity and Distress Inventory: Development, Validity and Reliability in Turkey
The goal of this observational study is to develop and validate a self-report inventory that assesses Polycystic Ovary Syndrome (PCOS) symptoms and the level of distress experienced by women diagnosed with PCOS. The main question it aims to answer is:
Is the newly developed inventory a valid and reliable instrument for assessing PCOS symptoms and related distress in women?
Participants will answer online survey questions including a demographic information form and three scales evaluating psychological health and PCOS related symptoms, including the newly developed symptom and distress inventory.
Detailed description
The research is a methodological scale development study.
A review of the literature reveals that despite strong evidence linking Polycystic Ovary Syndrome (PCOS) to anxiety, depression, and diminished quality of life, current assessment tools often fail to adequately represent psychological symptoms. There is a critical need for holistic and culturally sensitive instruments that address both the physical and psychological dimensions of PCOS. It is therefore thought that the developed scale will fill an important gap.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women diagnosed with PCOS | – | –Women aged 18-49 who report having been diagnosed with PCOS will be included in the study. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of women aged 18-49 who have been diagnosed with Polycystic Ovary Syndrome (PCOS). The study aims to reach a sample size of at least 85 to 170 participants. Women who meet the inclusion criteria and agree to participate on a voluntary basis will be invited to the study. Data will be collected via an online survey form prepared by the researchers. Participants will be recruited through social media platforms (such as WhatsApp and Instagram). To ensure ethical standards, an informed consent text will be included at the beginning of the online form, and a mandatory question will be used to confirm voluntary participation. Additionally, a mandatory screening question regarding PCOS diagnosis will be included to verify that participants meet the inclusion criteria; individuals without a PCOS diagnosis will be excluded from the sample.
Key inclusion criteria (3 listed)
- Being a woman aged 18-49 (of reproductive age) who states she has been diagnosed with PCOS
- Being able to read and understand Turkish
- Volunteering to participate in the study
Key exclusion criteria (1 listed)
- Having a disease that could cause symptoms similar to PCOS (such as Cushing's syndrome, thyroid dysfunction, hyperprolactinemia, androgen-secreting tumors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Polycystic Ovary Syndrome Symptom Severity and Distress Inventory
Time frame: At the time of survey completion (Baseline)
The newly developed inventory consists of 34 items in total, with 17 items dedicated to evaluating PCOS symptom severity and 17 items for measuring distress levels. Each item is scored on a scale from 0 to 10. Total scores are calculated separately for symptom severity and distress levels, with each score ranging from 0 to 100. Higher scores on these measurements indicate an increase in both symptom severity and the level of distress experienced by the participant.
3 secondary outcomes
Participant Information Form
Time frame: At the time of survey completion (Baseline)
Health-Related Quality of Life Questionnaire-50 for Polycystic Ovary Syndrome (PCOSQ-50)
Time frame: At the time of survey completion (Baseline)
Kessler Psychological Distress Scale (K10-PDS)
Time frame: At the time of survey completion (Baseline)
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 23 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the confidentiality and privacy of the participants.
Related trials for Polycystic Ovary Syndrome
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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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.
Melisa Bulut, PhD principal investigator
Abant Izzet Baysal University
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 Ovary Syndrome and Psychological Distress, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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 23 Feb 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 Turkey (Türkiye). 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?
Polycystic Ovary Syndrome Symptom Severity and Distress Inventory (time frame: At the time of survey completion (Baseline)). 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 23 Feb 2026.