Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-03 @ 2:20 AM
Study NCT ID:
NCT06813118
Status:
RECRUITING
Last Update Posted:
2025-02-06
First Post:
2024-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Clomid and Lezra With Lezra for Ovulation Induction in Clomid Resistant PCOS Case
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': 'D002996', 'term': 'Clomiphene'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], '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'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'lottery method for selection'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomization intervention RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-09-13', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the rate of ovulation', 'timeFrame': '6 months', 'description': 'To compare the rate of ovulation between letrozole alone and letrozole and CC'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovarian Syndrome']}, 'descriptionModule': {'briefSummary': 'Clomiphene citrate resistant i.e failure to ovulate after 6 cycles of ovulation induction effects 15-40% of patients with PCOS.Two treatment groups will be formed one recieving letrozole alone and another recieving CC and letrozole combined.Mature follicles and endometrial thickness will be checked by transvaginal ultrasound and results will be recorded.', 'detailedDescription': 'Subfertility is characterized by the inability to achieve conception despite engaging in regular unprotected sexual intercourse for 1-2 years.PCOS exhibits chacteristic traits such as obesity,heightened insulin resistance accompanied by compensatory hyperinsulinemia,oligo/anovulation and subfertility.Clompiphene citrate induces ovarian stimulation.Letrozole ,an aromatase inhibitor emerges as a novel medication with comparable efficacy to CC as a first line treatment for inducing ovulation in cases of anovulation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women of 20-40 years with a history of PCOS and resistant to CC\n\nExclusion Criteria:\n\n* Premature ovarian insufficiency\n* Husband has oligo azoospermia\n* Hypothyroidism\n* Hyperprolactinemia'}, 'identificationModule': {'nctId': 'NCT06813118', 'briefTitle': 'Comparison of Clomid and Lezra With Lezra for Ovulation Induction in Clomid Resistant PCOS Case', 'organization': {'class': 'OTHER', 'fullName': 'HITEC-Institute of Medical Sciences'}, 'officialTitle': 'A RCT Comparing the Effectiveness of a Combination Therapy of Lezra and Clomid Versus Lezra Alone for Inducing Ovulation in Women Diagnosed With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome', 'orgStudyIdInfo': {'id': 'HITECIMSTAXILLA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'clomiphene citrate and letrozole combination', 'interventionNames': ['Drug: Clomiphene Citrate and letrozole']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'letrozole alone', 'interventionNames': ['Drug: Clomiphene Citrate and letrozole']}], 'interventions': [{'name': 'Clomiphene Citrate and letrozole', 'type': 'DRUG', 'otherNames': ['drugs'], 'description': 'clomiphene citrate 100mg once daily along with letrozole 5mg to one group and letrozole 5mg to second group', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47080', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Rukhsana Shaheen Afzal, MBBS,FCPS', 'role': 'CONTACT', 'email': 'dr_rukh2006@yahoo.com', 'phone': '0333 9014943'}, {'name': 'Tahira Jabeen, MBBS,FCPS', 'role': 'CONTACT', 'phone': '0312 1519011'}, {'name': 'Rukhsana Shaheen Afzal, MBBS,FCPS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HIT Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'centralContacts': [{'name': 'Rukhsana Shaheen Afzal, MBBS,FCPS', 'role': 'CONTACT', 'email': 'dr_rukh2006@yahoo.com', 'phone': '03339014943'}, {'name': 'Tahira Jabeen, MBBS,FCPS', 'role': 'CONTACT', 'phone': '03121519011'}], 'overallOfficials': [{'name': 'Rukhsana Shaheen Afzal, MBBS,FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HITEC-Institute of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HITEC-Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rukhsana Shaheen Afzal', 'investigatorAffiliation': 'HITEC-Institute of Medical Sciences'}}}}