Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-31 @ 4:36 AM
Study NCT ID:
NCT01924104
Status:
UNKNOWN
Last Update Posted:
2013-08-16
First Post:
2013-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-15', 'studyFirstSubmitDate': '2013-08-12', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological pregnancy test', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Fetal heart/Gestational sac', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IVF failure, implantation rate, heparin & aspirin'], 'conditions': ['To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether low-dose aspirin and low molecular weight heparin improve the implantation and pregnancy rates in patients with repeated implantation failures in IVF cycle.', 'detailedDescription': 'The investigators hypothesize that cotreatment of low dose aspirin \\& low molecular weight heparin may improve implantation \\& clinical pregnancy rates.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 19 to 35 years;\n* Basal follicle-stimulating hormone (FSH) levels of ≤8 IU/l\n* Body mass index (BMI) between 19 kg/m2 and 25 kg/m2\n* Presence of both ovaries; ≥2 previous IVF failures\n* Good quality embryos for transfer\n* Endometrial thickness between 10 mm and 14 mm\n\nExclusion Criteria:\n\n* Polycystic ovary syndrome\n* Endometriosis'}, 'identificationModule': {'nctId': 'NCT01924104', 'briefTitle': 'Effects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.', 'organization': {'class': 'OTHER', 'fullName': 'Jeevan Jyoti Hospital'}, 'officialTitle': 'Effects of Low Dose Aspirin and Low Molecular Weight Heparin Cotreatment, Alone and/or in Combination on Implantation and Clinical Pregnancy Rates in Repeated Implantation Failures in IVF Cycle.', 'orgStudyIdInfo': {'id': 'JJH2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low Molecular Weight Heparin', 'description': 'Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously', 'interventionNames': ['Drug: Low molecular weight heparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose aspirin', 'description': 'Low dose aspirin, 75mg/day, orally', 'interventionNames': ['Drug: Low dose aspirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heparin & Aspirin', 'description': 'Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally)', 'interventionNames': ['Drug: Heparin & aspirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium chloride (NaCl)', 'description': 'Equivalent volume of NaCl 0.9%, subcutaneously', 'interventionNames': ['Other: NaCl']}], 'interventions': [{'name': 'Low molecular weight heparin', 'type': 'DRUG', 'otherNames': ['LMWH'], 'description': '2500 mIU/day, subcutaneously', 'armGroupLabels': ['Low Molecular Weight Heparin']}, {'name': 'Low dose aspirin', 'type': 'DRUG', 'otherNames': ['Ecoaspirin'], 'description': '75 mg/day, orally', 'armGroupLabels': ['Low dose aspirin']}, {'name': 'Heparin & aspirin', 'type': 'DRUG', 'otherNames': ['LMWH & Ecoaspirin'], 'description': 'Aspirin (70 mg/day, orally) \\& heparin (40 mg/day, subcutaneously)', 'armGroupLabels': ['Heparin & Aspirin']}, {'name': 'NaCl', 'type': 'OTHER', 'description': 'Equivalent volume of NaCl 0.9%, subcutaneously', 'armGroupLabels': ['Sodium chloride (NaCl)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '211003', 'city': 'Allahābād', 'state': 'Uttar Pradesh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Vandana Bansal, MS DGO PhD', 'role': 'CONTACT', 'email': 'bansal.drvandana@gmail.com', 'phone': '+91-0532-2417252', 'phoneExt': '402'}, {'name': 'Ashwani K Bansal, MS', 'role': 'CONTACT', 'email': 'arpitivf@gmail.com', 'phone': '+91-0532-2417252', 'phoneExt': '403'}, {'name': 'Vandana Bansal, MS DGO PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research Centre', 'geoPoint': {'lat': 29.22096, 'lon': 78.37997}}], 'centralContacts': [{'name': 'Vandana Bansal, MS DGO PhD', 'role': 'CONTACT', 'email': 'bansal.drvandana@gmail.com', 'phone': '+91-0532-2417252', 'phoneExt': '402'}, {'name': 'Ashwani K Bansal, MS', 'role': 'CONTACT', 'email': 'arpitivf@gmail.com', 'phone': '+91-0532-2417252', 'phoneExt': '403'}], 'overallOfficials': [{'name': 'Vandana Bansal, MS DGO PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Arpit Test Tube Baby Centre, Vandana Women's Hospital, Jeevan Jyoti Hospital & Research Centre"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr.Vandana Bansal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director & Consultant', 'investigatorFullName': 'Dr.Vandana Bansal', 'investigatorAffiliation': 'Jeevan Jyoti Hospital'}}}}