Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-29 @ 12:45 AM
Study NCT ID:
NCT02814695
Status:
COMPLETED
Last Update Posted:
2021-12-29
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yeast Cells as Antioxidant-Producing Probiotics
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015002', 'term': 'Yeast, Dried'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'control, vit E, vit C, Yeast'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-06-23', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total motile sperm', 'timeFrame': '30 minutes', 'description': 'Number of motile sperms in prepared semen sample per high power field (HPF)'}, {'measure': 'progressive motile sperm', 'timeFrame': '30 minutes', 'description': 'Number of progressively-motile sperms in prepared semen sample per HPF'}, {'measure': 'vitality', 'timeFrame': '30 minutes', 'description': 'Number of Vital sperms in prepared semen sample per HPF'}, {'measure': 'oxidative stress', 'timeFrame': '30 minutes', 'description': 'level of oxidative stress (OS) By Oxisperm Kit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Male infertility', 'oxidative stress', 'antioxidants', 'probiotics', 'Vitamin E', "Baker's Yeast"], 'conditions': ['Infertility, Male']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy of Baker's yeast extractions , probiotic antioxidant, in scavenging the oxidative stress status mediated damage on sperm motility,progressive motility and vitality as well as comparing this potency to that of Vitamin E in infertile men.", 'detailedDescription': "The practical part of the study took place from August 2020 to November 2021. The Study population was made up of infertile males attending Hawaa fertility center, banha city, Qaliubiya, Egypt.\n\n40 study samples were collected from patients who indicated willingness to participate in the study and have had 3 to 7 days of sexual abstinence, using the masturbation method and ejaculated in wide mouthed plastic container as described by World Health Organization (WHO).\n\nSamples were allowed to liquefy for 20 minutes and were examined for volume, viscosity, spermatozoa count by Neubauer haemocytometer , oxidative stress level measurement by Oxisperm, percentage of progressive motility and non-progressive motility and sperm vitality.\n\nThe Semen specimens were divided into ten equal fractions. First fraction was control, 0.1ml of liquefied semen mixed with 0.1ml Ham's F10 medium and incubated at 37o C for 30 minutes., 2nd: Vit. E, 3rd (Yeast extraction ( YE).Vitamin C was obtained from (Sigma, Germany), 3rd, 4th, 5th fractions (Vit. C. 1,2,3), 0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.02, 0.04, 0.06 mg/ml) Vitamin C respectively and incubated at 37o C for 30 minutes.\n\nAfter semen specimen treated in all fractions, they were examined and assessed for microscopical changes, total motility, progressive motility, vitality, level of oxidative stress (OS) were detected in all fractions 30 minutes later after addition of the antioxidants."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must have been married for 1 year before inclusion into the study and were unable to achieve pregnancy\n* must have not received an antibiotic treatment for the last 4 weeks prior to sampling\n* showed oxidative stress- mediated asthenozoospermia in their semen\n\nExclusion Criteria:\n\n* Severe male Factor'}, 'identificationModule': {'nctId': 'NCT02814695', 'acronym': 'Probiotics', 'briefTitle': 'Yeast Cells as Antioxidant-Producing Probiotics', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Can Yeast Cells Emulate Vitamin E on In-vitro Protection of Human Spermatozoa Against Oxidative Stress?', 'orgStudyIdInfo': {'id': 'HAWAA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "First fraction was control, 0.1ml of liquefied semen mixed with 0.1ml Ham's F10 medium and incubated at 37o C for 30 minutes."}, {'type': 'EXPERIMENTAL', 'label': 'Vit E supplementation', 'description': "0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (2 mg/ml) Vitamin E and incubated at 37o C for 30 minutes.", 'interventionNames': ['Dietary Supplement: Vit E']}, {'type': 'EXPERIMENTAL', 'label': 'Yeast supplementation', 'description': "0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (20 mg/ml) Yeast extraction and incubated at 37o C for 30 minutes.", 'interventionNames': ['Dietary Supplement: Yeast']}, {'type': 'EXPERIMENTAL', 'label': 'Vit C supplementation', 'description': "fractions (Vit. C. 1,2,3), 0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.02, 0.04, 0.06 mg/ml) Vitamin C respectively and incubated at 37o C for 30 minutes.", 'interventionNames': ['Dietary Supplement: Vit C 1', 'Dietary Supplement: Vit C 2', 'Dietary Supplement: Vit C 3']}], 'interventions': [{'name': 'Vit E', 'type': 'DIETARY_SUPPLEMENT', 'description': "0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (2 mg/ml) Vitamin E and incubated at 37o C for 30 minutes.", 'armGroupLabels': ['Vit E supplementation']}, {'name': 'Yeast', 'type': 'DIETARY_SUPPLEMENT', 'description': "0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (20 mg/ml) yeast extraction and incubated at 37o C for 30 minutes.", 'armGroupLabels': ['Yeast supplementation']}, {'name': 'Vit C 1', 'type': 'DIETARY_SUPPLEMENT', 'description': "0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.02 mg/ml) Vitamin C and incubated at 37o C for 30 minutes.", 'armGroupLabels': ['Vit C supplementation']}, {'name': 'Vit C 2', 'type': 'DIETARY_SUPPLEMENT', 'description': "0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.04 mg/ml) Vitamin C and incubated at 37o C for 30 minutes.", 'armGroupLabels': ['Vit C supplementation']}, {'name': 'Vit C 3', 'type': 'DIETARY_SUPPLEMENT', 'description': "0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.06 mg/ml) Vitamin C and incubated at 37o C for 30 minutes.", 'armGroupLabels': ['Vit C supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13512', 'city': 'Banhā', 'state': 'Qalyubia Governorate', 'country': 'Egypt', 'facility': 'hawaa Fertility center', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Ahmed S Saad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'not decided yet, but the data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hawaa Fertility Center', 'class': 'OTHER'}, {'name': 'Zagazig University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Ob.&Gyn.', 'investigatorFullName': 'Ahmed Saad', 'investigatorAffiliation': 'Benha University'}}}}