Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-03 @ 5:43 AM
Study NCT ID:
NCT07112768
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2025-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LH/FSH, Testosterone, Prolactin, and Ferritin in PCOS Patients in Jordan
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Five milliliters of venous blood were drawn and placed in simple test tubes for sample collection.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2025-08-02', 'studyFirstSubmitQcDate': '2025-08-02', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hormonal level', 'timeFrame': '3 months', 'description': 'Serum levels of LH, FSH, testosterone, prolactin'}, {'measure': 'Biochemical marker', 'timeFrame': '3 months', 'description': 'Serum level of Ferrtin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PCOS (Polycystic Ovary Syndrome)']}, 'descriptionModule': {'briefSummary': 'Polycystic Ovary Syndrome (PCOS) is a prevalent endocrine disorder impacting women of reproductive age. Characterized by chronic anovulation, hyperandrogenism, and the presence of multiple small ovarian cysts. Despite its widespread occurrence, a comprehensive study particularly within the Jordanian population remains limited. Aim of the study: The study aimed to assess the serum levels of the Luteinizing hormone (LH), Follicle stimulating hormone (FSH), LH/FSH ratio, Testosterone, Prolactin, and Ferritin in Jordanian women diagnosed with PCOS', 'detailedDescription': 'Polycystic Ovary Syndrome (PCOS) is a prevalent endocrine disorder impacting women of reproductive age. Characterized by chronic anovulation, hyperandrogenism, and the presence of multiple small ovarian cysts. Despite its widespread occurrence, a comprehensive study particularly within the Jordanian population remains limited. Aim of the study: The study aimed to assess the serum levels of the Luteinizing hormone (LH), Follicle stimulating hormone (FSH), LH/FSH ratio, Testosterone, Prolactin, and Ferritin in Jordanian women diagnosed with PCOS. Materials and Methods: A total 80 women aged between 20-41 years with confirmed PCOS diagnosis and 60 age matched healthy control were enrolled. Participant completed a structured questionnaire and provided informed consent .Blood samples were collected for measurement of LH, FSH, LH/FSH ratio, testosterone, prolactin, and ferritin levels using standardized laboratory protocol. Results: There were significant differences between the PCOS and control groups in the levels of LH, FSH, LH/FSH ratio, total testosterone, prolactin, and ferritin (p\\<0.05 for all). Specifically, the PCOS group showed higher levels of LH, testosterone, prolactin, and ferritin, while FSH levels were significantly lower. Additionally, positive correlations were observed between LH and testosterone, FSH and prolactin, and between ferritin and both LH and the LH/FSH ratio. Conclusions: The altered hormonal and biochemical profiles observed in PCOS patients emphasize the role of these biomarkers in diagnosing and understanding the pathophysiology of PCOS. These findings could support better clinical management and inform future research, particularly in the Jordanian patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '(n=140) females were included in the current study which were subdivided into two groups: the study group (n=80), comprising women aged 20 to 41 years who were diagnosed with PCOS based on the Rotterdam criteria (2003) as assessed by obstetric and gynecology specialist ; and the control group (n=60), consistening control women aged 22-41', 'genderDescription': '(n=140) females were included in the current study which were subdivided into two groups: the study group (n=80), comprising women aged 20 to 41 years who were diagnosed with PCOS based on the Rotterdam criteria (2003) as assessed by obstetric and gynecology specialist \\[14\\]; and the control group (n=60), consistening control women aged 22-41', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-45 PCOS diagnosed females Jordanian\n\nExclusion Criteria:\n\n* younger than 20 older than 45 Non -Jordanian'}, 'identificationModule': {'nctId': 'NCT07112768', 'acronym': 'PCOS patients', 'briefTitle': 'LH/FSH, Testosterone, Prolactin, and Ferritin in PCOS Patients in Jordan', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'The Role of LH/FSH, Testosterone, Prolactin, and Ferritin in PCOS Patients in Jordan', 'orgStudyIdInfo': {'id': 'Al-Ahliyya Amman University 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'control group (n=60), consisting control women aged 22-41 years', 'interventionNames': ['Diagnostic Test: Serum levels of LH, FSH, testosterone, prolactin, and ferritin']}, {'label': 'PCOs group', 'description': 'the study group (n=80), comprising women aged 20 to 41 years who were diagnosed with PCOS based on the Rotterdam criteria (2003) as assessed by obstetric and gynecology specialist', 'interventionNames': ['Diagnostic Test: Serum levels of LH, FSH, testosterone, prolactin, and ferritin']}], 'interventions': [{'name': 'Serum levels of LH, FSH, testosterone, prolactin, and ferritin', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['LH, FSH', 'testosterone', 'prolactin', 'ferritin'], 'description': 'Measurement of both hormonal and biochemical markers in Jordanian PCOs females, including Serum levels of LH, FSH, testosterone, prolactin, and ferritin)', 'armGroupLabels': ['Control group', 'PCOs group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amman', 'state': 'Amman Governorate', 'country': 'Jordan', 'facility': 'Al-Ahliyya Amman University', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The consent forms'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of clinical Pharmacy', 'investigatorFullName': 'Doaa Mohamed Salah ElDin Diab ELBohy', 'investigatorAffiliation': 'Al-Ahliyya Amman University'}}}}