Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT01841034
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2011-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of an Antioxidant Alimentary Complement on Sperm Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2015-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2011-09-26', 'studyFirstSubmitQcDate': '2013-04-25', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spermatic parameters (numeration and mobility spermatic)', 'timeFrame': 'At the inclusion and 6 months after the inclusion', 'description': 'The spermatic parameters used within the framework of the spermogramme made in routine in the Laboratory of Biology of the Reproduction will be the numeration and the spermatic mobility from the very beginning.'}], 'secondaryOutcomes': [{'measure': 'Rate of fragmentation of the DNA', 'timeFrame': 'At the inclusion and 6 months after the inclusion', 'description': 'We shall consider the rate of fragmentation of the DNA determined according to the method of the TUNEL. This technique allows to estimate the rate of spermatozoides apoptose. It brings to light the fragmentation of the spermatic DNA in the course of process of cellular death.'}]}, 'conditionsModule': {'keywords': ['Male'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Male infertility is a multifactorial disease process with a number of potential contributive causes. Considering the majority of male infertility cases are due to deficient sperm production of unknown origin, environmental and nutritional factors must be evaluated. The purpose of this study is to evaluate the effects of 6 months antioxidant dietary complement (Conceptio) on sperm parameters (sperm count, motility and DNA fragmentation) in infertile men with oligoasthenozoospermia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient receipt within the framework of the care of an infertility in the pole ORG, whatever is the étiologie and the type of treatment proposing and presenting during at least two spermogrammes an oligospermie and\\\\or an asthénospermie.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Number of sperm cells \\< 15M / mL and\\\\or mobility \\< 40 %.\n* Signature of a form of not opposition to the research.\n* Membership in a social security system.\n\nExclusion Criteria:\n\n* Number of sperm cells = 100M / mL.'}, 'identificationModule': {'nctId': 'NCT01841034', 'briefTitle': 'Impact of an Antioxidant Alimentary Complement on Sperm Data', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Evaluation of a 6 Months Treatment of Conceptio (EA) on Sperm Data in Infertile Men With Oligoasthenozoospermia', 'orgStudyIdInfo': {'id': '11-PP-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conceptio', 'description': 'Any patient receipt within the framework of the coverage(care) of an infertility in the pole ORG, whatever is the étiologie and the type of treatment proposing and presenting during at least two spermogrammes an oligospermie and\\\\or an asthénospermie. The necessity of realizing 2 spermogrammes different to determine the pathological character of the values of a spermogramme takes into account the personal variability of the results.', 'interventionNames': ['Drug: Conceptio EA']}], 'interventions': [{'name': 'Conceptio EA', 'type': 'DRUG', 'description': 'The patients are included during a consultation whether it is with a clinician or a biologist of the Center. It is suggested in routine in the service, to all the patients consulting for a problem of infertility and presenting pathological spermatic data, taking the food complement Conceptio. At the patients wishing to take this complement it will be suggested participating in this study. This complement is usually bought by the patient, within the framework of this study this one will be gracefully supplied. The follow-up of the patient will contain no examination and no anybody visit besides the usually realized follow-up.', 'armGroupLabels': ['Conceptio']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06001', 'city': 'Nice', 'state': 'Alpes-Maritimes', 'country': 'France', 'facility': "CHU de Nice - Hôpital de l'Archet", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'ISNARD Véronique, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CHU de Nice - CECOS- Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}