Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-04-15 @ 8:13 PM
Study NCT ID:
NCT02456792
Status:
WITHDRAWN
Last Update Posted:
2017-05-10
First Post:
2015-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVF Versus LOD in Women With CC Resistant PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020554', 'term': 'Sperm Injections, Intracytoplasmic'}], 'ancestors': [{'id': 'D005307', 'term': 'Fertilization in Vitro'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2015-05-23', 'studyFirstSubmitQcDate': '2015-05-28', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': '9 months', 'description': 'Number of live births divided by the number of women'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '6-8 weeks gestational age', 'description': 'Number of clinical pregnancies divided by the number of women'}, {'measure': 'Multifetal pregnancy rate', 'timeFrame': '12 weeks gestational age', 'description': 'Number of multifetal pregnancies divided by the number of clinical pregnancies'}, {'measure': 'Miscarriage rate', 'timeFrame': '12 weeks gestational age', 'description': 'Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies'}, {'measure': 'Incidence of early ovarian hyperstimulation syndrome (OHSS)', 'timeFrame': 'Within 9 days of final triggering of oocyte maturation', 'description': 'Incidence of OHSS within 9 days of final triggering of oocyte maturation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS', 'Clomiphene citrate resistant', 'LOD', 'IVF'], 'conditions': ['Infertility', 'Polycystic Ovarian Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).', 'detailedDescription': 'Women will be randomly divided into two groups; IVF group and LOD group. Women in the IVF group will undergo one full IVF cycle. Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile women with PCOS as defined by the Rotterdam criteria.\n* CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).\n\nExclusion Criteria:\n\n* Age \\< 20 or \\> 35 years.\n* Presence of any infertility factor other than anovulatory PCOS.\n* Previous history of ovarian surgery or surgical removal of one ovary.\n* Previous exposure to cytotoxic drugs or pelvic irradiation.\n* Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.\n* Metabolic or hormonal abnormalities.'}, 'identificationModule': {'nctId': 'NCT02456792', 'briefTitle': 'IVF Versus LOD in Women With CC Resistant PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'In Vitro Fertilization Versus Laparoscopic Ovarian Drilling in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome', 'orgStudyIdInfo': {'id': 'AG1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IVF group', 'description': 'Women will undergo one full IVF cycle', 'interventionNames': ['Procedure: IVF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LOD group', 'description': 'Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months', 'interventionNames': ['Procedure: LOD']}], 'interventions': [{'name': 'IVF', 'type': 'PROCEDURE', 'otherNames': ['Intracytoplasmic sperm injection (ICSI)'], 'description': 'Women will undergo one IVF cycle', 'armGroupLabels': ['IVF group']}, {'name': 'LOD', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopic ovarian diathermy'], 'description': 'Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months', 'armGroupLabels': ['LOD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Fertility Care Unit (FCU) in Mansoura University Hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Private fertility care centers', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ahmed Gibreel, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}, {'name': 'Mohamed S Abdelhafez, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Sayed Abdelhafez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohamed Sayed Abdelhafez', 'investigatorAffiliation': 'Mansoura University'}}}}