Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-04-01 @ 10:03 PM
Study NCT ID:
NCT06793904
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2025-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with successful ovulation', 'timeFrame': '5 days after treatment', 'description': 'the dominant follicle reached 18 or more mm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovarian Syndrome (PCOS)']}, 'descriptionModule': {'briefSummary': '122 women diagnosed with PCOS seeking fertility in the fertility clinic at kasr Alainy hospital will be subjected to Homeostatic model assessment for insulin resistance 1 was calculated for all participants through the equation \\[glucose (mmol/L) × insulin (µU/L)\\]/22.5 while homeostatic model assessment for insulin resistance 2 was calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations will be introduced as needed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'women diagnosed with PCOS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-35 years\n* duration of infertility 1-4 years\n* PCOS\n\nExclusion Criteria:\n\nwomen with other causes of infertility (tubal factor assessed by laparoscopy or hysterosalpingogram, uterine cavity abnormality assessed by ultrasound or hysteroscopy or male factor assessed by seme analysis),\n\n* endometriosis,\n* ovarian cysts,\n* endocrinological abnormalities (Diabetes mellitus, hypothalamic, pituitary or thyroid disorders, or hyperprolactinemia),\n* women with history of poor ovarian response or ovarian hyperstimulation\n* women with chronic diseases, chromosomal, autoimmune or coagulation defects, abnormal leucocytic count or other inflammatory markers\n* Women with contraindications to pregnancy.'}, 'identificationModule': {'nctId': 'NCT06793904', 'briefTitle': 'Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'N 364-2024'}, 'secondaryIdInfos': [{'id': 'Cairo university', 'type': 'OTHER', 'domain': 'Cairo university'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCOS', 'description': 'Homeostatic model assessment for insulin resistance 1 will be calculated for all participants through the equation \\[glucose (mmol/L) × insulin (µU/L)\\]/22.5 while homeostatic model assessment for insulin resistance 2 will be calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations were introduced as needed.', 'interventionNames': ['Drug: Aromatase inhibitor Letrozole']}], 'interventions': [{'name': 'Aromatase inhibitor Letrozole', 'type': 'DRUG', 'description': '2.5 mg tab twice daily from the 3rd day of the cycle for 5 days', 'armGroupLabels': ['PCOS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12111', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '01005227404'}], 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'dr_ahmedmaged08@kasralainy.edu.eg', 'phone': '01005227404'}, {'name': 'Ahmed Chamel, MD', 'role': 'CONTACT', 'email': 'ahmed-chamel@hotmail.com', 'phone': '+20 110 066 2255'}], 'overallOfficials': [{'name': 'Ahmed Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ahmed M Maged, MD', 'investigatorAffiliation': 'Cairo University'}}}}