Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT02775734
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2016-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NAC in CC Resistant PCOS After LOD
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D002996', 'term': 'Clomiphene'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical pregnancy rate', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '6 months'}, {'measure': 'Live-birth rate', 'timeFrame': '15 months'}, {'measure': 'Ovulation rate', 'timeFrame': '6 months'}, {'measure': 'follicles more than or equal 18 mm', 'timeFrame': '6 months'}, {'measure': 'Pre-ovulatory endometrial thickness', 'timeFrame': '6 months'}, {'measure': 'mid-luteal sub-endometrial doppler blood flow indices', 'timeFrame': '6 months'}, {'measure': 'Incidence of side effects', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome', 'N-acetyl-cysteine', 'Clomiphene citrate', 'Clomiphene citrate resistant', 'Laparoscopic ovarian drilling', 'therapy'], 'conditions': ['Clomiphene Citrate Resistant Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'This prospective randomized placebo-controlled double blind clinical trial will conducted in Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200 mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation, mid- luteal sub-endometrial blood flow indices, and incidence of side effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) between 25 and 30 Kg/m 2.\n* CC-resistant Polycystic ovary syndrome\n\nExclusion Criteria:\n\n* • Patients with BMI under 25 or over 30 Kg/m 2.\n\n * Hyper or hypothyroidism, or hyperprolactinemia.\n * Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.\n * Intention to start a diet or a specific program of physical activity.\n * Organic pelvic diseases.\n * Tubal or male factor infertility.\n * Interval of earlier treatment with any of the fertility drugs of less than 6 months.\n * Contraindication to either:\n\n * Clomiphene citrate: liver disease, undiagnosed abnormal uterine bleeding, uterine fibroids, endometrial cancer, ovarian enlargement or hyper stimulation\n * HCG injection: ovarian enlargement or hyper stimulation'}, 'identificationModule': {'nctId': 'NCT02775734', 'acronym': 'NAC', 'briefTitle': 'NAC in CC Resistant PCOS After LOD', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AS1275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'N-acetyl-cysteine', 'description': 'N-acetyl-cysteine + Clomiphene citrate + LOD', 'interventionNames': ['Drug: N-acetyl-cysteine', 'Drug: Clomiphene citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NO N-acetyl-cysteine', 'description': 'Clomiphene citrate + LOD', 'interventionNames': ['Drug: Clomiphene citrate']}], 'interventions': [{'name': 'N-acetyl-cysteine', 'type': 'DRUG', 'description': 'N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling', 'armGroupLabels': ['N-acetyl-cysteine']}, {'name': 'Clomiphene citrate', 'type': 'DRUG', 'description': 'Clomiphene citrate + Laparoscopic ovarian drilling', 'armGroupLabels': ['N-acetyl-cysteine', 'NO N-acetyl-cysteine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohamed S Sweed, MD', 'investigatorAffiliation': 'Ain Shams University'}}}}