Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT04302532
Status:
COMPLETED
Last Update Posted:
2020-11-25
First Post:
2020-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}, {'id': 'D002996', 'term': 'Clomiphene'}], 'ancestors': [{'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'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2020-03-09', 'lastUpdatePostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of ovulating women', 'timeFrame': '1-2 months', 'description': 'transvaginal ultrasound as the disappearance of the leading follicle, presence of follicular fluid in the Douglas pouch and midluteal progesterone \\>5 pg/ml.'}, {'measure': 'number of pregnancies', 'timeFrame': '1-2 months', 'description': 'ultrasound visualization of gestational sac with pulsating fetal pole'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovulation induction', 'coenzyme q10', 'pregnancy rate'], 'conditions': ['Coenzyme q10']}, 'descriptionModule': {'briefSummary': 'The study evaluates the effect of coenzyme q 10 on ovulation and subsequent pregnancy in women with polycystic ovarian syndrome. Half of the participants will receive coq10 and ovulation induction with clomiphene and other half would receive a placebo with clomiphene.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of polycystic ovarian syndrome PCOS based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS (2003).\n* All women were previously treated with 100 mg of CC daily for 5 days per cycle, for two to three cycles with persistent anovulation or ovulate with very thin endometrium \\<5 mm at the time of hCG administration\n\nExclusion Criteria:\n\n* Non-consenting.\n* known autoimmune disorders\n* prior treatment of endometriosis or surgery to reproductive tract\n* prior history of pelvic inflammatory disease\n* those with tubal factors and uterine factors as assessed on history and confirmed by normal hysterosalpingogram.\n* Thyroid disorder as assessed by history examination and TSH level\n* Patients with raised FSH'}, 'identificationModule': {'nctId': 'NCT04302532', 'briefTitle': 'Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Karachi Medical and Dental College'}, 'officialTitle': 'Combined Coenzyme Q10 and Clomiphene Citrate for Ovulation Induction in Clomiphene-citrate-resistant Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clomiphene', 'description': 'clomiphene citrate 150 mg once a day for 5 days', 'interventionNames': ['Drug: clomiphene citrate']}, {'type': 'EXPERIMENTAL', 'label': 'clomiphene and coenzyme q10', 'description': 'clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day', 'interventionNames': ['Drug: Coenzyme Q10', 'Drug: clomiphene citrate']}], 'interventions': [{'name': 'Coenzyme Q10', 'type': 'DRUG', 'otherNames': ['celeron sr'], 'description': 'antioxidant used to decrease oxidative stress and improve fertility prospects', 'armGroupLabels': ['clomiphene and coenzyme q10']}, {'name': 'clomiphene citrate', 'type': 'DRUG', 'otherNames': ['clomid'], 'description': 'ovulation induction drug', 'armGroupLabels': ['Clomiphene', 'clomiphene and coenzyme q10']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74600', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Aziz medical center', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Rubina Izhar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aziz Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karachi Medical and Dental College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical investigator', 'investigatorFullName': 'samia husain', 'investigatorAffiliation': 'Karachi Medical and Dental College'}}}}