Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT04758260
Status:
WITHDRAWN
Last Update Posted:
2021-02-17
First Post:
2020-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men Whose Partners Will Undergo Through an Egg Donation Cycle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000975', 'term': 'Antioxidants'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'difficulty recruiting', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the sORP rate in sperm samples,', 'timeFrame': '2.5 months', 'description': 'Compare the sORP rate in sperm samples, obtained by the Mioxsys System, before and after 2.5 months antioxidant men supplements treatment (Fertybiotic MAN).'}], 'secondaryOutcomes': [{'measure': 'Evaluate the influence of the sORP rate in embryo development', 'timeFrame': '1 year', 'description': 'Analysis of different embryo quality parameters as:\n\n* fecundation rate\n* percentage of blastocyst stage arrival embryos\n* number of frozen embryos'}, {'measure': 'Evaluate the relationship between the sORP rate in sperm samples', 'timeFrame': '1 year', 'description': 'Evaluate the relationship between the sORP rate in sperm samples, obtained by Mioxsys System, with the implantation rate, on-going pregnancy rate and miscarriage rate.'}, {'measure': 'Determinate a reproductive prognosis value based on sORP rate and the different sperm parameters', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Compare the sORP Rate in Sperm Samples, Obtained by the Mioxsys System, Before and After 2.5 Months Antioxidant Men Supplements Treatment (Fertybiotic Man)']}, 'descriptionModule': {'briefSummary': "Evaluate the influence of antioxidant men supplements treatment (Fertybiotic Hombre) in the rate of sORP (stactic Oxidation Reduction Potential) defined as the balanced measure between the total oxidant activity (ROS, superoxides, nitric oxide, peroxide) and total reducing activity (alpha tocopherol, β carotene, uric acid) in sperm samples during egg donation cycles.\n\nWe will also evaluate the influence of the sORP rate in the embryo development during the egg donation treatments; taking in account the fecundation rate, percentage of blastocyst stage arrival embryos, number of frozen embryos, implantation rate, on-going pregnancy rate and miscarriage rate.\n\nThe sperm sample will be measured by electrochemical technology using Mioxsys system for a quantitative measurement in millivolts (mV), in those male patients who participate in an egg donation assisted reproduction treatment.\n\nAfter 14 days, the pregnancy stage will be available. This information will be obtained from the patient's clinical history using the human chorionic gonadotropin hormone (shCG) in blood. It will be performed either in our Clinic or externally within the usual practice derived from the treatment carried out. These values will be compared with the results obtained from sORP."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Male Inclusion Criteria\n\n* Sperm count greater than 2 million per milliliter\n* Sperm origin: ejaculate\n\nExclusion Criteria:\n\n* Taking oral antioxidants in the 3 months prior to inclusion in the study\n* Total astenozoospermia or Severe teratozoospermia (including balloonzoospermia)'}, 'identificationModule': {'nctId': 'NCT04758260', 'acronym': 'Mioxsys ox', 'briefTitle': 'Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men Whose Partners Will Undergo Through an Egg Donation Cycle', 'organization': {'class': 'OTHER', 'fullName': 'IVI Bilbao'}, 'officialTitle': 'Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men Whose Partners Will Undergo Through an Egg Donation Cycle', 'orgStudyIdInfo': {'id': '1708-BIO-088-MM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antioxidant Treatment', 'description': 'Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men', 'interventionNames': ['Dietary Supplement: Antioxidant']}], 'interventions': [{'name': 'Antioxidant', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral antioxidant oral intake in the 3 months prior to inclusion in the study', 'armGroupLabels': ['Antioxidant Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48940', 'city': 'Leioa', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'IVI Bilbao', 'geoPoint': {'lat': 43.32686, 'lon': -2.98884}}], 'overallOfficials': [{'name': 'Marcos Ferrando', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Bilbao'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Bilbao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aytu BioPharma, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Marcos Ferrando Serrano', 'investigatorFullName': 'FERNANDO QUINTANA FERRAZ', 'investigatorAffiliation': 'IVI Bilbao'}}}}