Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05302856
Status:
UNKNOWN
Last Update Posted:
2022-08-23
First Post:
2022-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
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': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CMV antibody ratio serum/semen', 'timeFrame': 'Through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sperm', 'blood testis barrier', 'cmv antibody', 'unexplained infertility'], 'conditions': ['Male Infertility']}, 'referencesModule': {'references': [{'pmid': '24424039', 'type': 'BACKGROUND', 'citation': 'Haverfield JT, Meachem SJ, Nicholls PK, Rainczuk KE, Simpson ER, Stanton PG. Differential permeability of the blood-testis barrier during reinitiation of spermatogenesis in adult male rats. Endocrinology. 2014 Mar;155(3):1131-44. doi: 10.1210/en.2013-1878. Epub 2013 Jan 1.'}, {'pmid': '27353840', 'type': 'BACKGROUND', 'citation': 'Stanton PG. Regulation of the blood-testis barrier. Semin Cell Dev Biol. 2016 Nov;59:166-173. doi: 10.1016/j.semcdb.2016.06.018. Epub 2016 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'To assess whether the presence of Cytomegalovirus (CMV) Immunoglobulin G (IGG) antibodies in semen is a reliable predictor of male subfertility or infertility.', 'detailedDescription': 'Prospective cohort study performed in the artificial reproductive technology (ART) unit.\n\nThe study will evaluate semen and serum samples from the following groups:\n\n1. Presumably fertile male patients going through ART treatment (for preimplantation genetic testing (PGT) or female indications).\n2. Subfertile/infertile male patients with abnormal semen analysis.\n3. Male patients suffering from unexplained infertility. All samples will be collected on the day of ovum retrieval procedure, and the semen samples will be evaluated only after completing the fertilization process. The samples will be tested for CMV IGG antibodies and testosterone levels in semen and serum. In addition, anti-sperm antibodies will be measured in the serum. The ratio between CMV IGG antibodies in semen and serum will be calculated, and will be compared with presence of hormone profile, semen analysis parameters and ART parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All male patients addressing the infertility unit in Hadassah Mt Scopus for IVF procedure\n\nExclusion Criteria:\n\n* Refusal to participate\n* Male partner utilizing pre cycle frozen sperm sample\n* Donor sperm cycles\n* Surgically retrieved sperm'}, 'identificationModule': {'nctId': 'NCT05302856', 'briefTitle': 'CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage', 'orgStudyIdInfo': {'id': 'IGGSEMEN-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Presumably fertile male patients going through ART treatment', 'interventionNames': ['Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)']}, {'type': 'EXPERIMENTAL', 'label': 'Subfertile/infertile male patients with abnormal semen analysis', 'interventionNames': ['Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)']}, {'type': 'EXPERIMENTAL', 'label': 'Male patients suffering from unexplained infertility', 'interventionNames': ['Diagnostic Test: Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)']}], 'interventions': [{'name': 'Blood test (CMV IGG, Anti sperm antibody, Testosterone levels)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Peripheric blood extraction', 'armGroupLabels': ['Male patients suffering from unexplained infertility', 'Presumably fertile male patients going through ART treatment', 'Subfertile/infertile male patients with abnormal semen analysis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '00 972 2 6777572'}, {'name': 'Chana Adler Lazarovits, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Chana Adler Lazarovits, MD', 'role': 'CONTACT', 'email': 'chanaa@hadassah.org.il', 'phone': '00 972 50 8779068'}, {'name': 'Anat Hershko klement, MD', 'role': 'CONTACT', 'email': 'anathk@hadassah.org.il'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chana Adler', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}