Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 4:01 PM
Study NCT ID:
NCT01683435
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2012-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of HBA in the Evaluation of Idiopathic Infertility
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2012-09-07', 'studyFirstSubmitQcDate': '2012-09-07', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In each of these groups we will assess presence of HBA bound sperm', 'timeFrame': 'immediate at time of preforming HBA test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor', 'detailedDescription': 'We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor We would like to determine if patients with abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate, implantation rate, and increased miscarriage rate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups\n\n 1. Abnormal Semen Analysis (sperm count \\<10 million/ml and /or rapid progressive motility \\< 50 %, WHO morphology \\<30%) normal HSG , normal ovarian reserve testing and ovulation testing\n 2. Unexplained infertility- normal ovarian reserve testing and ovulation testing (FSH\\< 10, AMH\\>1.0) Normal ovulatory cycles, normal WHO semen analysis. Normal tubes on HSG or Laparoscopy\n 3. Tubal infertility as assessed by HSG or laparoscopy\n\nExclusion Criteria:\n\n* women over 40, prior failed IVF'}, 'identificationModule': {'nctId': 'NCT01683435', 'briefTitle': 'The Value of HBA in the Evaluation of Idiopathic Infertility', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's-Roosevelt Hospital Center"}, 'officialTitle': 'The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility', 'orgStudyIdInfo': {'id': 'IRB 11-134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hylauronin binding assay', 'description': 'HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.', 'interventionNames': ['Other: HBA binding assay']}], 'interventions': [{'name': 'HBA binding assay', 'type': 'OTHER', 'description': 'HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.', 'armGroupLabels': ['hylauronin binding assay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Continuum Reproductive Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Martin Keltz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Mount Sinai St. Luke's"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's-Roosevelt Hospital Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}