Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-26 @ 12:59 AM
Study NCT ID:
NCT01315093
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2011-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2011-03-08', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'no of oocytes retrieved', 'timeFrame': 'egg recovery, 2 years', 'description': '\\>2 between groups'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '2 years', 'description': 'Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks'}, {'measure': 'live birth rate', 'timeFrame': '2 years', 'description': '\\>20 weeks of gestation'}, {'measure': 'cancellation rate', 'timeFrame': 'before ET, 2 years'}, {'measure': 'miscarriage rate', 'timeFrame': '2 years', 'description': 'pregnancy loss \\<20 weeks'}]}, 'conditionsModule': {'keywords': ['In Vitro Fertilisation', 'poor responders'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* poor responders (age\\>40, abnormal ovarian test, \\</=4 oocytes in previous cycle with conventional stimulation)\n* infertility, indication for IVF\n* no contraindications for heparin'}, 'identificationModule': {'nctId': 'NCT01315093', 'briefTitle': 'Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'orgStudyIdInfo': {'id': '123456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heparin, Low-Molecular-Weight group', 'description': 'LMWH was administered during an IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders. Drug was started at the beginning of the cycle and stopped at the time of pregnancy test if negative, or continued if pregnancy occurred until the 32th weeks of gestation', 'interventionNames': ['Drug: Heparin, Low-Molecular-Weight']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non Heparin, Low-Molecular-Weight group', 'description': 'IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders.', 'interventionNames': ['Drug: no heparin']}], 'interventions': [{'name': 'Heparin, Low-Molecular-Weight', 'type': 'DRUG', 'description': 'Heparin from start till hcg test', 'armGroupLabels': ['Heparin, Low-Molecular-Weight group']}, {'name': 'no heparin', 'type': 'DRUG', 'armGroupLabels': ['Non Heparin, Low-Molecular-Weight group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12642', 'city': 'Athens', 'state': 'Chaidari', 'country': 'Greece', 'facility': '3rd Department of Obstetrics & Gynecology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Director of the ARU', 'investigatorFullName': 'Siristatidis Charalampos, MD, PhD', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}