Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT06181851
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
2015-Metabolomics&Microbiome-infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564665', 'term': 'Azoospermia, Nonobstructive'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prognostic role of the blood and semen samples', 'timeFrame': 'Baseline', 'description': 'Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Azoospermia, Nonobstructive']}, 'descriptionModule': {'briefSummary': 'The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.', 'detailedDescription': 'The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.\n\nFurthermore, the study aims to assess if the blood and seminal alterations of infertile patients have similarities with the same fluids of elderly patients, validating from a metabolomic and microbiomic point of view the hypothesis of premature aging of infertile patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "* diagnosis of idiopathic non-obstructive azoospermia\n* fertile men (pregnancy within 12 months from the start of the couple's search)\n* men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching)", 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosis of idiopathic non-obstructive azoospermia\n* fertile men (pregnancy within 12 months from the start of the couple's search)\n* men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching)\n\nExclusion Criteria:\n\n* diagnosis of varicocele\n* endocrine alterations\n* chromosomal alterations\n* known genetic alterations"}, 'identificationModule': {'nctId': 'NCT06181851', 'briefTitle': '2015-Metabolomics&Microbiome-infertility', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Microbiome and Metabolomics Analysis in a Population of Infertile Patients Suffering From Non-obstructive Azospermia and Examination of Their Impact on the Reproductive Potential and Global Health of the Individual', 'orgStudyIdInfo': {'id': 'Metabolomicsµbiome'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infertile men', 'description': 'Patients diagnosed with idiopathic non-obstructive azoospermia', 'interventionNames': ['Other: Analysis of microbiome and metabolomics']}, {'label': 'Fertile men', 'description': 'fertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria)', 'interventionNames': ['Other: Analysis of microbiome and metabolomics']}, {'label': 'Old fertile men', 'description': 'Subjects known to have been fertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria)', 'interventionNames': ['Other: Analysis of microbiome and metabolomics']}], 'interventions': [{'name': 'Analysis of microbiome and metabolomics', 'type': 'OTHER', 'description': 'Analysis of microbiome and metabolomics through the assessment of blood and semen parameters', 'armGroupLabels': ['Fertile men', 'Infertile men', 'Old fertile men']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Alessia d'Arma, PhD", 'role': 'CONTACT', 'email': 'darma.alessia@hsr.it', 'phone': '02 2643 5506'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Andrea Salonia, MD', 'role': 'CONTACT', 'email': 'salonia.andrea@hsr.it', 'phone': '02 2643 5661'}, {'name': "Alessia d'Arma, MSc", 'role': 'CONTACT', 'email': 'darma.alessia@hsr.it', 'phone': '02 2643 5506'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrea Salonia', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}