Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-29 @ 10:29 PM
Study NCT ID:
NCT05702957
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007246', 'term': 'Infertility'}], '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': 'D000077289', 'term': 'Letrozole'}, {'id': 'D002996', 'term': 'Clomiphene'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Two treatment groups were made by random computer generated number i.e. Group A and Group B. Two Concealed boxes labelling A and B containing study drugs were made by pharmacist.Then participants were given drug from concealed boxes according to computer generated number.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Total 230 patients were randomized in study, divided in two groups by computer generated numbers, out of which 220 patients were analyzed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '5th week of cycle when periods missed', 'description': 'Total number of patients conceived after treatment'}], 'secondaryOutcomes': [{'measure': 'ovulation rate', 'timeFrame': '10-22 day of cycle', 'description': 'when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone.'}, {'measure': 'Live birth rate', 'timeFrame': '9 months', 'description': 'total number of live births divided by total number of patients in a group'}, {'measure': 'Monofollicular development', 'timeFrame': '10-12 day of menstrual cycle', 'description': 'when only one follicle achieve diameter of greater than or equal to 18mm'}, {'measure': 'Multifollicular development', 'timeFrame': '10-12 day of menstrual cycle', 'description': 'when 2 or more follicles achieve diameter of \\>12mm'}, {'measure': 'Miscarraige', 'timeFrame': 'Less than 24weeks', 'description': 'spontaneous loss of pregnancy before 24 weeks of gestation'}, {'measure': 'Adverse effects', 'timeFrame': 'first 10days of cycle', 'description': 'hot flushes.'}, {'measure': 'Adverse effects', 'timeFrame': 'first 10days of cycle', 'description': 'Fatigue and dizziness'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polycystic ovary syndrome', 'Infertility', 'Clomiphene citrate', 'Letrozole'], 'conditions': ['Polycystic Ovary Syndrome', 'Infertility']}, 'referencesModule': {'references': [{'pmid': '38196458', 'type': 'DERIVED', 'citation': 'Wasim T, Nasrin T, Zunair J, Irshad S. Efficacy of Letrozole vs Clomiphene Citrate for induction of ovulation in women with polycystic ovarian syndrome. Pak J Med Sci. 2024 Jan-Feb;40(1Part-I):78-83. doi: 10.12669/pjms.40.1.7971.'}]}, 'descriptionModule': {'briefSummary': 'It was randomised controlled study to compare the efficacy of clomiphene and letrozole in polycystic ovarian syndrome(PCOS) women with infertility.The aim was to select more appropriate treatment for ovulation induction in PCOS women.', 'detailedDescription': 'The prevalence of infertility due to polycystic ovarian syndrome in Pakistan is 21.9%.It leads to an ovulation which results in infertility.The objective of this study was to compare the efficacy of letrozole vs clomiphene citrate for ovulation induction in PCOS women.Methods.It was a randomised controlled trial conducted in department of gynaecology and obstetrics ,Services Hospital Lahore from 2016-2019.\n\nTotal 230 patients were included in study, they were divided in two groups, out of which 220 patients were analysed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days. Transvaginal ultrasound monitoring done from day 10-12 of menstrual cycle to measure follicle number and size.When follicle achieved a diameter of 18-20mm, then Inj HCG(human chorionic gonadotropin)10,000 IU intramuscular was given. Ovulation was confirmed by day 21 S.progesterone. When patient conceived, they were followed up till delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age between 18-40 years.\n* Normal husband semen analysis.\n\nExclusion Criteria:\n\n* All infertile couples who had other causes of infertility than PCOS.\n* Those who had recently taken these medications.\n* Any contraindication to use of drugs e.g renal or hepatic dysfunction, hypersensitivity to this drug.\n* BMI\\>35 because obese women respond poorly to ovulation induction.'}, 'identificationModule': {'nctId': 'NCT05702957', 'briefTitle': 'Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Services Institute of Medical Sciences, Pakistan'}, 'officialTitle': 'Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial', 'orgStudyIdInfo': {'id': 'IRB/2015/209/SIMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'letrozole', 'description': 'Patients were given letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.', 'interventionNames': ['Drug: letrozole 2.5mg-7.5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clomiphene citrate', 'description': 'Patients were given clomiphene citrate 50-150mg per day for 5 days started from 2nd day of the menses.', 'interventionNames': ['Drug: Clomiphene Citrate 50mg-150mg']}], 'interventions': [{'name': 'letrozole 2.5mg-7.5mg', 'type': 'DRUG', 'otherNames': ['tab lezra 2.5-7.5mg'], 'description': 'Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.', 'armGroupLabels': ['letrozole']}, {'name': 'Clomiphene Citrate 50mg-150mg', 'type': 'DRUG', 'otherNames': ['tab clomid 50-150mg'], 'description': 'Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.', 'armGroupLabels': ['Clomiphene citrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Services Institute of Medical sciences', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Services Institute of Medical Sciences, Pakistan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Obstetrics & Gynaecology', 'investigatorFullName': 'Tayyiba Wasim', 'investigatorAffiliation': 'Services Institute of Medical Sciences, Pakistan'}}}}