Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT00741494
Status:
COMPLETED
Last Update Posted:
2010-12-28
First Post:
2008-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 801}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'lastUpdateSubmitDate': '2010-12-26', 'studyFirstSubmitDate': '2008-08-25', 'studyFirstSubmitQcDate': '2008-08-25', 'lastUpdatePostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '8 weeks post ICSI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infertility', 'ICSI', 'hyaluronan binding', 'sperm', 'sperm selection', 'male factor', 'hyaluronan', 'sperm maturity', 'clinical pregnancy rates', 'hyaluronan binding assay', 'HBA', 'PICSI'], 'conditions': ['Male Factor Infertility']}, 'referencesModule': {'references': [{'pmid': '23203216', 'type': 'DERIVED', 'citation': 'Worrilow KC, Eid S, Woodhouse D, Perloe M, Smith S, Witmyer J, Ivani K, Khoury C, Ball GD, Elliot T, Lieberman J. Use of hyaluronan in the selection of sperm for intracytoplasmic sperm injection (ICSI): significant improvement in clinical outcomes--multicenter, double-blinded and randomized controlled trial. Hum Reprod. 2013 Feb;28(2):306-14. doi: 10.1093/humrep/des417. Epub 2012 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select sperm for ICSI will result in increased pregnancies especially with men that have a low hyaluronan binding score (HBA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IVF patients who require the ICSI procedure and whose care is being managed by the clinical and scientific staff of the participating groups, will be included in the study.\n\nExclusion Criteria:\n\n* IVF patients who do not require the ICSI procedure will be excluded from the study. In addition the following groups of patients will also be excluded:\n\n * Patients using testicular sperm.\n * Patients using donor sperm.\n * Patients where the female partner is over 40 years of age\n * Patients who have an initial HBA score less than or equal to 2%\n * Patients who have a sperm count less than or equal to 10,000 motile sperm per ml.\n * Patients who produce less than 4 Metaphase II oocytes'}, 'identificationModule': {'nctId': 'NCT00741494', 'briefTitle': 'Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocoat'}, 'officialTitle': 'Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI) for Patients Having a Low Versus High Proportion of Hyaluronan Binding Sperm (HBA)', 'orgStudyIdInfo': {'id': '2008PICSI03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'HBA score over 65% control'}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores)'}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'HBA score over 65%. PICSI dish is used to select the sperm for ICSI.', 'interventionNames': ['Device: PICSI dish']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'HBA score less than 65%. PICSI dish used to select sperm for ICSI.', 'interventionNames': ['Device: PICSI dish']}, {'type': 'NO_INTERVENTION', 'label': '5', 'description': 'HBA Score less than 65%. Control'}], 'interventions': [{'name': 'PICSI dish', 'type': 'DEVICE', 'description': 'Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI', 'armGroupLabels': ['3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Huntington Reproductive Center', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'Reproductive Science Center of the Bay Area', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Reproductive Specialists', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Reproductive Biology Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Fertility Centers of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '13205', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'CNY Fertility Center', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington IVF and Genetics Toll Center for Reprodcution', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Reproductive Medicine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Kathryn Worrilow, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biocoat'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocoat', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kathryn Worrilow', 'oldOrganization': 'Biocoat, Inc.'}}}}