Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT02851966
Status:
UNKNOWN
Last Update Posted:
2019-03-12
First Post:
2016-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-08', 'studyFirstSubmitDate': '2016-07-11', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful testicular sperm retrieval', 'timeFrame': '2 years', 'description': 'This outcome will be measured by if sperms would be found during the procedure or if sperms would be identified in the IVF clinic.'}], 'secondaryOutcomes': [{'measure': 'Natural variation in sperm counts in semen', 'timeFrame': '2 years', 'description': 'Variation in sperm concentration in semen as measured by direct microscopic assessment of different semen samples provided by each of the participants.'}, {'measure': 'Natural variation in semen TEX101 concentration', 'timeFrame': '2 years', 'description': 'Variation in TEX101 concentrations in semen of different semen samples provided by each of the participants as measured by the TEX101 ELISA assay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-obstructive Azoospermia', 'Sperm Retrieval', 'Infertility, Male', 'Semen', 'Biomarkers', 'Proteomics', 'Enzyme-Linked Immunosorbent Assay'], 'conditions': ['Non-obstructive Azoospermia']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that sperm production varies with time in men with no sperm in semen (non-obstructive azoospermia, NOA) and that the semen protein, TEX101, is able to monitor these changes. The investigators further hypothesize that TEX101 levels may be used to predict the optimum time for microsurgical testicular sperm extraction (mTESE) to provide the highest successful rates of sperm retrieval.', 'detailedDescription': 'This is a non-randomized pilot study. All men with NOA, who may or may not consider having mTESE, will be approached to enter this study.\n\nRecruited men will have a semen test performed at the initial visit (time 0) to measure semen TEX101 levels using an ELISA assay.\n\nFor men who are not considering a mTESE to retrieve sperm, the TEX101 semen levels will be measured monthly for three months to determine the variability of semen TEX101.\n\nFor men who are considering a mTESE in an attempt to retrieve sperm, the mTESE procedure to retrieve sperm will be booked. If the level of TEX101 is detectable at time 0, then the men will have semen testing monthly. If the TEX101 is persistently detectable then the men will have surgery at the time originally scheduled. If the TEX101 drops on any subsequent test to be undetectable, then the semen testing for TEX101 will continue monthly for a maximum of 3 additional months. If the TEX101 remains undetectable for all tests, the men will have the mTESE at the end of the additional 3 months. If the TEX101 is detectable on a subsequent test, then the men will undergo an immediate mTESE (\\< 2 weeks).\n\nIf the initial TEX101 is undetectable, then the men will have monthly semen testing for TEX101 for a maximum of 3 additional tests. If the TEX101 remains persistently undetectable, then a mTESE will be performed as originally booked. If the TEX101 is detected on a subsequent test, then an immediate mTESE (\\< 2 weeks) is performed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with NOA by standard clinical means with a minimum of 2 semen tests confirming that the man is azoospermic\n* Ability to understand the study and consent\n* Ability to deliver semen samples\n\nExclusion Criteria:\n\n* Men do not have NOA\n* Cannot understand the study and consent\n* Cannot provide semen samples'}, 'identificationModule': {'nctId': 'NCT02851966', 'briefTitle': 'Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia', 'orgStudyIdInfo': {'id': 'CAN-TEX-P1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TEX101', 'description': 'This is a single arm study. All patients will be asked to provide multiple semen samples and all samples will be tested with TEX101 ELISA assay. Timing of mTESE maybe changed according to the assay results.', 'interventionNames': ['Procedure: mTESE']}], 'interventions': [{'name': 'mTESE', 'type': 'PROCEDURE', 'description': 'mTESE time may be postponed or advanced.', 'armGroupLabels': ['TEX101']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 'QC H3T 1M5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Keith Jarvi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Hospital, Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, {'name': 'McGill University', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}