Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-25 @ 6:31 PM
Study NCT ID:
NCT02683057
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2016-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Physical Exercise on Semen Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012746', 'term': 'Sexual Abstinence'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-04', 'studyFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2016-02-10', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ascertain the influence of physical activity in sperm quality to candidates for sperm donors in the donation program according to the universally accepted questionnaire International physical activity (IPAQ)', 'timeFrame': '2 years', 'description': 'Semen parameters will be evaluated according to WHO criteria blinded on clinical and data analyst.\n\nInternational Physical Activity Questionnaire (IPAQ) offers before sperm donation quantifying the activity "walk", "activities of moderate intensity" and "vigorous intensity activities" assigned to each activity about energy requirements defined in METs, being multiples of the rate of metabolic rate equivalent to kilocalories for a 60 kg.\n\nThe median and interquartile range (between Q1 and Q3) is calculated for walking (W), activities of moderate intensity (M), activities of vigorous intensity (V) and a combined result of total physical activity. All results must be expressed as continuous METminutos / week.'}], 'secondaryOutcomes': [{'measure': 'Existence of confounding factors associated with physical activity', 'timeFrame': '2 years', 'description': 'The existence of confounding factors such as age, tobacco, weight, BMI, alcohol, drugs, type of sport will be cleaned and blood parameters associated with physical activity will be defined.\n\nA data tab/sheet for each donor was made . The existence of related factors such as age, tobacco, weight, BMI, alcohol, drug and the type of sport exercised were been analysed.\n\nIt categorizes the population into quartiles depending on their activity and determine which is which is associated with a better seminal quality the same debugging is made confounding previously mentioned.\n\nmultivariate analysis to determine the correlation between physical activity and sperm parameters'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sexual Abstinence']}, 'descriptionModule': {'briefSummary': 'Our study addresses a previously selected population or by physical activity but not for semen quality semen donor candidates donation program within the clinic.\n\nTotal physical activity was analyzed according to the universally accepted international physical activity questionnaire (IPAQ) The existence of confounding factors associated She purge age, snuff, weight, BMI, alcohol, drugs, type of sport and associated blood parameters determinations will be made to exercise.', 'detailedDescription': 'The level of physical activity recommended great unknown and its influence from the therapeutic point of view to improve semen quality.\n\nFor it will be held:\n\n* 3 groups of physical activity are established, according to their score in the IPAQ: High, minimum of physical activity between \\> 1500 MET week Moderate: minimum of physical activity of between 600- 1500 MET week Low : until \\< 600 MET week\n* Implementation of a double analysis: Seminal and hormonal\n* Standardization of confounding factors associated with the individual'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Candidates for sperm donors in the donation program which aims clinic It is performed in 432 cases. For that, our study addresses a population previously selected either by physical activity or by semen quality', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Appear as sperm donor\n* Age between 18-35 years\n* First sperm donation\n* Sexual abstinence 3-5 days\n* Having signed informed consent\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02683057', 'briefTitle': 'Influence of Physical Exercise on Semen Quality', 'organization': {'class': 'OTHER', 'fullName': 'IVI Bilbao'}, 'officialTitle': 'Influence of Physical Exercise on Semen Quality', 'orgStudyIdInfo': {'id': '1411-BIO-080-RM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IPAQ HIgh', 'description': 'Excessive physical activity:IPAQ quantifying the activity physical according vigorous intensity activities at least 3 days per week adding a minimum total physical activity of at least 1500MET-minutes / week or 7 or more days any combination of walking, moderate intensity or vigorous intensity activities a total minimum of physical activity of at least 3,000 MET-minutes / week', 'interventionNames': ['Other: International Physical Activity Questionnaire (IPAQ)']}, {'label': 'IPAQ Moderate', 'description': 'Ideal Physical activity: IPAQ quantifying the activity physical according 3 days or more of vigorous intensity physical activity at least 20 minutes per day or 5 or more days of moderate intensity and / or walk at least 30 minutes per day or 5 or more days of any combination of walking, moderate-intensity activity and activity vigorous intensity for a total minimum of physical activity of at least 600 MET-minutes / week.', 'interventionNames': ['Other: International Physical Activity Questionnaire (IPAQ)']}, {'label': 'IPAQ Low', 'description': 'IPAQ quantifying the activity physical according Insufficient physical activity: Individuals who can not put on the criteria of the above categories.', 'interventionNames': ['Other: International Physical Activity Questionnaire (IPAQ)']}], 'interventions': [{'name': 'International Physical Activity Questionnaire (IPAQ)', 'type': 'OTHER', 'description': 'all candidates for sperm donors clinic IVI IVI Bilbao and Valencia were will provide the international physical activity questionnaire (IPAQ) attached to analyze the total physical activity. This will be self-completed questionnaire beforeSperm donation. (Appendix 1) Age, snuff, weight, BMI, alcohol, drug use and the type of sport that practices will be analyzed: Additionally a tab for each donor collecting the existence of associated factors be drawn. (Appendix 2)', 'armGroupLabels': ['IPAQ HIgh', 'IPAQ Low', 'IPAQ Moderate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48011', 'city': 'Leioa', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'IVI Bilbao', 'geoPoint': {'lat': 43.32686, 'lon': -2.98884}}], 'overallOfficials': [{'name': 'Roberto Matorras', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Bilbao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Bilbao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}