PCOS- Polycystic Ovary SyndromeNCT05010551
Translation and Validation of MPCOSQ in Urdu Language
An observational study of PCOS- Polycystic Ovary Syndrome, run by Riphah International University at 2 sites in Pakistan.
Trial summary
To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ) questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of modified polycystic ovary syndrome quality of life questionnaire (MPCOQ). Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- PCOS- Polycystic Ovary Syndrome
- How many people
- 180 participants
- Where
- 2 sitesPakistan
- Study dates
- 20 Nov 2020to 30 Aug 2021
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients diagnosed with PCOS
Who may be able to join
- • Age 18 - 30
- Married
- Female patients diagnosed with PCOS, having 2 of the following Rotterdam diagnostic criteria:
- Polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume >10ml II. Clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score >7 or obvious acne) III. Having an interval between menstrual periods >35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days Patients who are willing to participate
Who cannot join
- • Non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia
- Female undergoing Hormone Replacement Therapy
- Female with malignancies
- Any recent fractures, surgeries
- Patient with nephrological and neurological conditions
- Dementia or cognitive impairments
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Abeer Fatima
Islamabad, Punjab Province, 45000
Zohra Institute of Health Sciences
Rawalpindi
About this study
Official title: Translation and Validation of Modified Polycystic Ovary Syndrome Questionnaire in Urdu Language
To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ) questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of modified polycystic ovary syndrome quality of life questionnaire (MPCOQ).
Read the detailed description
- All statistical analyses will be conducted using the Statistical Product and Service Solution version 21 software.
- Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage.
- In this study, factor structure of the (MPCOQ) will be analyzed using the principal component factor analysis with varimax rotation.
- Intraclass Correlation Coefficient (ICC) (95% confidence interval) will be used for test-retest value and Cronbach's Alpha will be used for internal consistency analysis.
- Measurement error will be determined by calculating the standard error of measurement (SEM) and the Smallest Detectable Change (SDC). Independent t-test will be used to determine the differences between groups
- Conditions
- PCOS- Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified polycystic ovary syndrome quality of life questionnaire
The tool is to measure health related quality of life of females suffering from PCOS. it contains 30 items with 6 main areas related to hirsutism , acne, weight, infertility, emotional disturbance, menstrual difficulties to define different symptoms of PCOS. then quality of life will be measured of respective patients. The total is 210 with higher score indicating a better quality of life.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start20 Nov 2020
- Primary completion30 May 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS- Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Ehsan, Principal investigator, Riphah International UniversityAbeer Fatima, MS(cppt), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010551
- Sponsor's protocol ID
- REC/00843 Rabbiya Zaman
- Status last verified
- Apr 2022
- First submitted
- 11 Aug 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of Modified Polycystic Ovary Syndrome Questionnaire in Urdu Language
- ClinicalTrials.gov ID
- NCT05010551
- Acronym / sponsor ID
- REC/00843 Rabbiya Zaman
- Conditions
- PCOS- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 18 Aug 2021 (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.
To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ) questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of modified polycystic ovary syndrome quality of life questionnaire (MPCOQ).
Detailed description
- All statistical analyses will be conducted using the Statistical Product and Service Solution version 21 software.
- Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage.
- In this study, factor structure of the (MPCOQ) will be analyzed using the principal component factor analysis with varimax rotation.
- Intraclass Correlation Coefficient (ICC) (95% confidence interval) will be used for test-retest value and Cronbach's Alpha will be used for internal consistency analysis.
- Measurement error will be determined by calculating the standard error of measurement (SEM) and the Smallest Detectable Change (SDC). Independent t-test will be used to determine the differences between groups
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with PCOS
Key inclusion criteria (4 listed)
- • Age 18 - 30
- Polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume >10ml II. Clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score >7 or obvious acne) III. Having an interval between menstrual periods >35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days Patients who are willing to participate
Key exclusion criteria (6 listed)
- • Non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia
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
Modified polycystic ovary syndrome quality of life questionnaire
Time frame: 6 months
The tool is to measure health related quality of life of females suffering from PCOS. it contains 30 items with 6 main areas related to hirsutism , acne, weight, infertility, emotional disturbance, menstrual difficulties to define different symptoms of PCOS. then quality of life will be measured of respective patients. The total is 210 with higher score indicating a better quality of life.
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 28 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Sarah Ehsan principal investigator
Riphah International University
Abeer Fatima, MS(cppt) principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS- Polycystic Ovary Syndrome, run by Riphah International University at 2 sites in Pakistan.
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 4 inclusion and 6 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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Modified polycystic ovary syndrome quality of life questionnaire (time frame: 6 months). 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 28 Apr 2022.