Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-04-20 @ 8:53 AM
Study NCT ID:
NCT02475395
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gsommer@sandstonedx.com', 'phone': '9253157246', 'title': 'Cheif Science Officer', 'phoneExt': '925', 'organization': 'Sandstone Diagnostics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Donor/Tester Subjects', 'description': 'Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement', 'otherNumAtRisk': 258, 'otherNumAffected': 0, 'seriousNumAtRisk': 258, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tester Only Subjects', 'description': 'Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Untrained Lay Users That Obtained Accurate and Inaccurate Subfertility Results From the TRAK Device When Compared to Results Obtained From the Gold Standard', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donor/Tester Subjects', 'description': 'Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}, {'id': 'OG001', 'title': 'Tester Only Subjects', 'description': 'Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}], 'classes': [{'categories': [{'title': 'True Positive Trak Results', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'True Negative Trak Results', 'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'False Positive Trak Results', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'False Negative Trak Results', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '90.0', 'ciLowerLimit': '79.9', 'ciUpperLimit': '95.3', 'estimateComment': 'Sensitivity estimates the percent true positive results obtained by Trak. Positive results are less than 15 M/mL sperm concentration and are part of a sub fertile diagnostic assessment.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.3', 'ciLowerLimit': '88.7', 'ciUpperLimit': '96.1', 'estimateComment': 'Specificity is calculated by the percentage of true negative results obtained using Trak compared to reference method. Negative (for subfertility) results are greater than 15 M/mL.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for one visit for up to 2 hours', 'description': 'Lay users obtained categorical sperm concentration result. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Gold standard reference (analysis by Computer-aided Semen Analysis \\[CASA\\]) result was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match gold standard reference category result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donor/Tester Subjects', 'description': 'Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}, {'id': 'OG001', 'title': 'Tester Only Subjects', 'description': 'Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}], 'classes': [{'categories': [{'title': 'True Positive Trak Results', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'True Negative Trak Results', 'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'False Positive Trak Results', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'False Negative Trak Results', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '95.0', 'ciLowerLimit': '86.3', 'ciUpperLimit': '98.3', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '94.9', 'ciLowerLimit': '90.6', 'ciUpperLimit': '97.3', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for one visit for up to 2 hours', 'description': 'Healthcare professions obtained a categorical sperm concentration result by observing completed assay outputs as performed by Lay Users. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donor/Tester Subjects', 'description': 'Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}, {'id': 'OG001', 'title': 'Tester Only Subjects', 'description': 'Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}], 'classes': [{'categories': [{'title': 'True Positive Trak Results', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'True Negative Trak Results', 'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'False Positive Trak Results', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'False Negative Trak Results', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '96.7', 'ciLowerLimit': '88.7', 'ciUpperLimit': '99.1', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.8', 'ciLowerLimit': '89.2', 'ciUpperLimit': '96.5', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for one visit for up to 2 hours', 'description': "Healthcare professions obtained a categorical sperm concentration result by performing assay on aliquot obtained from Lay User's sample. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One fewer was analyzed in this population because a sample did not have enough sample to allow the HCP to run the test.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Donor/Tester Subjects', 'description': 'Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}, {'id': 'FG001', 'title': 'Tester Only Subjects', 'description': 'Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '258'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Men were recruited at three medical clinic sites from 2 September 2015 to 4 December 2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Donor/Tester Subjects', 'description': 'Male subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}, {'id': 'BG001', 'title': 'Tester Only Subjects', 'description': 'Male or female subjects use the TRAK device to attain a measurement of sperm concentration from a semen specimen\n\nTRAK device: Use of TRAK to attain sperm concentration measurement'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '40'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '27.5', 'upperLimit': '35.5'}, {'value': '34', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '39'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-15', 'studyFirstSubmitDate': '2015-06-09', 'resultsFirstSubmitDate': '2017-06-21', 'studyFirstSubmitQcDate': '2015-06-15', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-21', 'studyFirstPostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Untrained Lay Users That Obtained Accurate and Inaccurate Subfertility Results From the TRAK Device When Compared to Results Obtained From the Gold Standard', 'timeFrame': 'Participants will be followed for one visit for up to 2 hours', 'description': 'Lay users obtained categorical sperm concentration result. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Gold standard reference (analysis by Computer-aided Semen Analysis \\[CASA\\]) result was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match gold standard reference category result.'}], 'secondaryOutcomes': [{'measure': 'Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.', 'timeFrame': 'Participants will be followed for one visit for up to 2 hours', 'description': 'Healthcare professions obtained a categorical sperm concentration result by observing completed assay outputs as performed by Lay Users. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.'}, {'measure': "Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.", 'timeFrame': 'Participants will be followed for one visit for up to 2 hours', 'description': "Healthcare professions obtained a categorical sperm concentration result by performing assay on aliquot obtained from Lay User's sample. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result."}]}, 'conditionsModule': {'keywords': ['Male Fertility', 'Male Infertility', 'Fertility', 'Sperm', 'Sperm Concentration'], 'conditions': ['Fertility, Male', 'Sub-Fertility, Male']}, 'referencesModule': {'references': [{'pmid': '27887718', 'type': 'DERIVED', 'citation': 'Schaff UY, Fredriksen LL, Epperson JG, Quebral TR, Naab S, Sarno MJ, Eisenberg ML, Sommer GJ. Novel centrifugal technology for measuring sperm concentration in the home. Fertil Steril. 2017 Feb;107(2):358-364.e4. doi: 10.1016/j.fertnstert.2016.10.025. Epub 2016 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the agreement in measurement of sperm concentration in human semen between lay users with TRAK and a recognized reference method. The study will also include the measurement of matched samples by TRAK when tested by healthcare professionals trained in use of the TRAK device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects (Donor/Tester)\n\n* Generally healthy (apart from fertility or reproductive care), ambulatory, and have absence of chronic conditions or treatments, except those related to fertility and reproductive care\n* 20 - 50 years of age inclusive\n* Male sex (subjects providing and/or testing human semen specimens)\n* For males providing human semen specimens, either healthy subjects or men receiving health care for any one or more of the following reasons:\n\n * Partner in a couple having difficulty conceiving\n * Diagnosed with male factor infertility\n * Post-vasectomy patients\n * Post-vasectomy reversal patients\n\nTesters Only\n\n* Be able to provide signed Informed Consent\n* 20 - 50 years of age inclusive\n\nExclusion Criteria:\n\n* Any medical or personal issue that would impair the ability of the subject to adhere to the protocol (e.g. substance abuse, neurological disorders)\n* Patients currently taking investigational drugs or who are active participants in a treatment trial for any condition\n* Unable to speak, understand, or write English\n* Mental illness that would interfere with understanding during the discussion of Informed Consent or that would compromise ability to follow the study protocol including, but not limited to, review of the TRAK™ Instructional Booklet, semen specimen collection, and semen specimen testing.'}, 'identificationModule': {'nctId': 'NCT02475395', 'briefTitle': 'Study of the Consumer Use of a New Home Test to Measure Sperm Concentration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandstone Diagnostics'}, 'officialTitle': 'A Clinical Study Evaluating Consumer Use of a New Device (TRAK) to Measure Sperm Concentration From Human Semen Samples, and Comparing TRAK Test Results With Laboratory Reference Method Testing', 'orgStudyIdInfo': {'id': 'SD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Donor/Tester Subjects', 'description': 'Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen', 'interventionNames': ['Device: TRAK device']}, {'type': 'EXPERIMENTAL', 'label': 'Tester Only Subjects', 'description': "Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen.", 'interventionNames': ['Device: TRAK device']}], 'interventions': [{'name': 'TRAK device', 'type': 'DEVICE', 'otherNames': ['Sperm Concentration'], 'description': 'Use of TRAK to attain sperm concentration measurement', 'armGroupLabels': ['Donor/Tester Subjects', 'Tester Only Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'California Reproductive Services: Huntington Reproductive Center', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '91536', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'San Fernando Valley Urological Associates Medical Group', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': "Men's Fertility Laboratory", 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}], 'overallOfficials': [{'name': 'Eugene Dula, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Fernando Valley Urological Associates Medical Group'}, {'name': 'Robert Boostanfar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Reproductive Services: Huntington Reproductive Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandstone Diagnostics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}