Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-02 @ 7:23 AM
Study NCT ID:
NCT07016035
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translation and Validation of the French mPCOSQ (mPCOSQ-F).
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-05-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Content validity of mPCOSQ as determined by the experts group', 'timeFrame': 'At 2 years'}, {'measure': 'Feasibility of mPCOSQ', 'timeFrame': 'At 2 years'}, {'measure': 'Acceptability of mPCOSQ', 'timeFrame': 'At 2 years'}, {'measure': 'Structure validity of mPCOSQ', 'timeFrame': 'At 2 years'}, {'measure': 'Reproductibility of mPCOSQ', 'timeFrame': 'At 2 years'}, {'measure': 'Reliabilty of mPCOSQ', 'timeFrame': 'At 2 years'}, {'measure': 'Total mPCSOQ score', 'timeFrame': 'At 15 days'}, {'measure': 'SF-36 scores', 'timeFrame': 'At 1 day'}, {'measure': 'Scores in the " weight " domain based on BMI', 'timeFrame': 'At 1 day'}, {'measure': 'Scores in the " fertility " domain based on the need for reproductive medicine or parenthood', 'timeFrame': 'At 1 day'}, {'measure': 'Scores in the " hirsutism " domain based on the Ferriman-Gallwey score', 'timeFrame': 'At 1 day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polycystic ovary syndrome', 'PCOS', 'quality of life', 'health-related quality of life', 'mPCOSQ', 'questionnaire', 'SF-36', 'French'], 'conditions': ['Polycystic Ovary Syndrome Health-related Quality of Life']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, observational, bicentric study, evaluating the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.\n\nThe first stage of the study consisted in translating the questionnaire from English to French.\n\nPatients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.', 'detailedDescription': 'The aim of this study is to assess the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.\n\nWomen aged 18 to 45 years with a diagnosis of polycystic ovary syndrome will be included.\n\nThe first stage of the study consisted in translating the questionnaire from English to French.\n\nPatients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.\n\nThe pre-test phase purpose is to appraise the face validity and feasibility of the questionnaire through phone interviews with the thirty first respondents.\n\nIn the final phase, we aimed to evaluate the validity and reliability of the mPCOSQ, and to compare it to the SF-36.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were PCOS women recruited from the Reims University Hospital and the Charleville-Mézières Hospital when presenting to endocrinology, gynaecology or reproductive medicine consults.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Women aged 18 to 45\n* Fluent in french\n* Having a diagnosis of PCOS according to the international recommendations published in 2023\n* Willing to participate in the study\n* Affiliated to the french social security system\n\nExclusion criteria:\n\n* Diagnosis of adrenal hyperplasia, androgen-producing tumor, Cushing's syndrome, or thyroid disorder\n* Pregnancy or breast-feeding\n* Under legal protection"}, 'identificationModule': {'nctId': 'NCT07016035', 'briefTitle': 'Translation and Validation of the French mPCOSQ (mPCOSQ-F).', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Translation and Validation of the French Version of the Health-related Quality of Life Questionnaire for the Polycystic Ovary Syndrome: the mPCOSQ-F.', 'orgStudyIdInfo': {'id': 'PS25052'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Polycystic ovary syndrome', 'description': 'patients with Polycystic ovary syndrome', 'interventionNames': ['Other: mPCOSQ-F and SF-36']}], 'interventions': [{'name': 'mPCOSQ-F and SF-36', 'type': 'OTHER', 'description': 'Questionnaires', 'armGroupLabels': ['Polycystic ovary syndrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sara BARRAUD', 'role': 'CONTACT', 'email': 'sbarraud@chu-reims.fr', 'phone': '03 10 73 63 82', 'phoneExt': '0033'}, {'name': 'Camille TETU', 'role': 'CONTACT', 'email': 'ctetu@chu-reims.fr'}], 'facility': 'Damien JOLLY', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Sara BARRAUD', 'role': 'CONTACT', 'email': 'sbarraud@chu-reims.fr', 'phone': '03 10 73 63 82', 'phoneExt': '0033'}, {'name': 'Camille TETU', 'role': 'CONTACT', 'email': 'ctetu@chu-reims.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}