Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-02 @ 12:11 AM
Study NCT ID:
NCT05010551
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translation and Validation of MPCOSQ in Urdu Language
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified polycystic ovary syndrome quality of life questionnaire', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PCOS- Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "* All statistical analyses will be conducted using the Statistical Product and Service Solution version 21 software.\n* Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage.\n* In this study, factor structure of the (MPCOQ) will be analyzed using the principal component factor analysis with varimax rotation.\n* 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.\n* 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"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with PCOS', 'genderDescription': 'Married Diagnosed with PCOS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age 18 - 30\n\n * Married\n * Female patients diagnosed with PCOS, having 2 of the following Rotterdam diagnostic criteria:\n\nI. 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\n\nExclusion Criteria:\n\n* • Non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia\n\n * Female undergoing Hormone Replacement Therapy\n * Female with malignancies\n * Any recent fractures, surgeries\n * Patient with nephrological and neurological conditions\n * Dementia or cognitive impairments'}, 'identificationModule': {'nctId': 'NCT05010551', 'briefTitle': 'Translation and Validation of MPCOSQ in Urdu Language', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Translation and Validation of Modified Polycystic Ovary Syndrome Questionnaire in Urdu Language', 'orgStudyIdInfo': {'id': 'REC/00843 Rabbiya Zaman'}}, 'contactsLocationsModule': {'locations': [{'zip': '45000', 'city': 'Islamabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Abeer Fatima', 'geoPoint': {'lat': 29.7426, 'lon': 73.14353}}, {'city': 'Rawalpindi', 'country': 'Pakistan', 'facility': 'Zohra Institute of Health Sciences', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Sarah Ehsan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}, {'name': 'Abeer Fatima, MS(cppt)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}