Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-01 @ 3:17 AM
Study NCT ID:
NCT06832735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health-related Quality of Life of Women with Polycystic Ovary Syndrome At Sohag University Hospital
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 352}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'health related quality of life of women with PCOS', 'timeFrame': '2 months after answering the polycystic ovary syndrome questionnaire', 'description': 'The quality of life of the participants will be studied using Polycystic Ovary Syndrome Questionnaire (PCOSQ), which consists of 26 questions and 5 domains ,including emotions (eight questions), body hair (five questions), weight (five questions), infertility (four questions), and menstrual problems (four questions)'}], 'secondaryOutcomes': [{'measure': 'Factors affecting health related quality of life of women with PCOS', 'timeFrame': '2 months after collecting data from the medical chart', 'description': 'by medical chart developed by the investigator and the supervisors that will include Socio-demographic data of the women with PCOS, medical history and body measurements.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS', 'Quality of life', 'PCOSQ', 'BMI'], 'conditions': ['Polycystic Ovary Syndrome (PCOS) Women']}, 'descriptionModule': {'briefSummary': 'It is well-established that PCOS women suffer from anxiety, depression, and markedly reduced QoL ,but There has not yet been a nationally representative study to evaluate the PCOS health related Qol and factors affecting it among women in Egypt. So here we try to cover this gap in this study that will be designed to record the QOL of women with PCOS and factors affecting it.\n\nThis study aims to assess the health related quality of life of polycystic ovary syndrome and determine factors affecting the HRQOL'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women with PCOS visiting Gynecology and clinical nutrition outpatient clinics at Sohag university hospital during the period of 6 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Female cases between 18 and 45.\n\n * Females diagnosed with PCOS per Rotterdam criteria , the most commonly accepted and used for PCOS, a diagnosis is confirmed if any two of the three features (hyperandrogenism, oligomenorrhea or anovulation, and polycystic ovaries) are present in a woman of reproductive age\n\nExclusion Criteria:\n\n* • Females below 18 years old.\n\n * Females above 45 years old.\n * Patients having major life event or problem also affecting quality of life.'}, 'identificationModule': {'nctId': 'NCT06832735', 'briefTitle': 'Health-related Quality of Life of Women with Polycystic Ovary Syndrome At Sohag University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Health-related Quality of Life of Women with Polycystic Ovary Syndrome At Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-25-2--3MD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with Polycystic ovary syndrome', 'description': 'women with PCOS visiting Gynecology and clinical nutrition outpatient clinics at Sohag university hospital\n\nInclusion criteria:\n\n* Female cases between 18 and 45.\n* Females diagnosed with PCOS per Rotterdam criteria , the most commonly accepted and used for PCOS, a diagnosis is confirmed if any two of the three features (hyperandrogenism, oligomenorrhea or anovulation, and polycystic ovaries) are present in a woman of reproductive age\\[7\\].\n\nExclusion criteria:\n\n* Females below 18 years old.\n* Females above 45 years old.\n* Patients having major life event or problem also affecting quality of life.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'faculty of medicine Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Samah Wagdy Elkhayat, Assistant lecturer', 'role': 'CONTACT', 'email': 'samahwagdy@med.sohag.edu.eg', 'phone': '+201006300880'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of family medicine', 'investigatorFullName': 'Samah Wagdy Abdelaziz', 'investigatorAffiliation': 'Sohag University'}}}}