Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 8:15 PM
Study NCT ID:
NCT04778033
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2021-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Semen Analysis Parameters Following Pfizer's COVID-19 Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Semen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-27', 'studyFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2021-02-27', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm Concentration (10^6/ml)', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Semen concentration (10\\^6/ml)'}, {'measure': 'Sperm Motility (%)', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Sperm percentage with proper forward progression'}, {'measure': 'White Blood Cells (10^6/ml) in Semen', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Amount of white blood cells (10\\^6/ml) in semen'}, {'measure': 'Sperm Morphology (%)', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Sperm morphology (%)'}, {'measure': 'Sperm Vitality (%)', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Sperm vitality (%)'}, {'measure': 'Semen Liquefaction (normal/abnormal)', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Macroscopic appearance - Semen liquefaction appearance'}, {'measure': 'Semen Viscosity (normal/abnormal)', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Macroscopic appearance - Semen viscosity appearance'}, {'measure': 'Semen Color', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Macroscopic appearance - Semen color appearance'}, {'measure': 'Semen PH', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Semen PH'}, {'measure': 'Semen Volume (ml)', 'timeFrame': '1-2 months after the second COVID-19 vaccine', 'description': 'Semen Volume (ml)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Fertility Issues']}, 'descriptionModule': {'briefSummary': 'In this study the investigators will explore the effect of the BNT162b2 COVID-19 Vaccine on semen analysis parameters among 75 fertile men. Fertile men will be regarded as such if they previously successfully impregnated their partners without the use of artificial reproductive technology, or men who previously had a normal sperm analysis exam by WHO criteria (2010). Those recruited will supply a single sperm sample 1-2 months following the second dose of the vaccination. In addition, the participants will fill a brief questionnaire with information regarding their medical and reproductive history. The investigators will examine the macroscopic and microscopic properties of the semen samples and compare them to the WHO semen analysis reference range in an attempt to ascertain whether the vaccine influences sperm parameters.', 'detailedDescription': 'The 2019 novel coronavirus disease (COVID-19) is a highly infectious respiratory tract disease which was first reported in Wuhan, Hubei Province, China in Dec 2019, but has since spread globally. By march 2020 it was declared by WHO as a public health emergency pandemic and has thus far affected tens of millions worldwide. The implications of COVID 19 infection on male fertility were examined in a previous study, which found decreased sperm concentration in recovering patients compared with controls.\n\nThe newly available mRNA COVID 19 vaccine by Pfizer was recently evaluated in a large multicenter placebo controlled RCT. The vaccine is comprised of BNT162b2, a lipid nanoparticle formulated nucleoside-modified RNA (modRNA) encoding the SARS-CoV2 full length spike protein, modified by two Proline mutations. The two 20 µg doses were shown to elicit high SARS-COV2 neutralizing antibody titers alongside high antigen specific CD8+ and Th1 type CD4+ T cell response. It was subsequently shown to be 95% effective in preventing COVID-19 infection a week following the second dose with a favorable safety profile in a 2-month median following up time.\n\nUnfounded claims in the popular media linked a possible correlation between the COVID-19 vaccine and potential female\\\\male infertility. Currently. there is no information in the medical literature which examined semen analysis parameters following the COVD-19 vaccine.\n\nIn this study the investigators will explore the effect of the BNT162b2 COVID-19 Vaccine on semen analysis parameters among 75 fertile men. Fertile men will be regarded as such if they previously successfully impregnated their partners without the use of artificial reproductive technology, or men who previously had a normal sperm analysis exam by WHO criteria (2010). Those recruited will supply a single sperm sample 1-2 months following the second dose of the vaccination. In addition, the participants will fill a brief questionnaire with information regarding their medical and reproductive history. The investigators will examine the macroscopic and microscopic properties of the semen samples and compare them to the WHO semen analysis reference range in an attempt to ascertain whether the vaccine influences sperm parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fertile men 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously impregnated their partner without the use of assisted reproduce technology, or previously had a normal sperm analysis exam by WHO 2010 criteria.\n* 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine.\n\nExclusion Criteria:\n\n* Known abnormal semen parameters.\n* Age above 45.'}, 'identificationModule': {'nctId': 'NCT04778033', 'briefTitle': "Semen Analysis Parameters Following Pfizer's COVID-19 Vaccine", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Effect of BNT162b2 mRNA COVID-19 Vaccine on Semen Analysis Parameters Among 75 Fertile Men', 'orgStudyIdInfo': {'id': 'SHEBA - 21 - 8079- JH - CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccinated Men', 'description': 'Fertile men who were vaccinated with the BNT162b2 COVID-19 Vaccine', 'interventionNames': ['Other: Sperm collection']}], 'interventions': [{'name': 'Sperm collection', 'type': 'OTHER', 'description': 'Those recruited will supply a single sperm sample 1-2 months following the second dose of the vaccination. The sample will be analyzed for macroscopic and microscopic features in the IVF laboratory and will be discarded immediately afterwards.', 'armGroupLabels': ['Vaccinated Men']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jigal Haas, M.D', 'role': 'CONTACT', 'email': 'jigalh@hotmail.com', 'phone': '0972524651054'}, {'name': 'Jigal Haas, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Jigal Haas, MD', 'role': 'CONTACT', 'email': 'jigal.haas@sheba.health.gov.il', 'phone': '972-54-6975372'}, {'name': 'Dror Lifshitz, MD', 'role': 'CONTACT', 'email': 'dror_lifshitz@hotmail.com', 'phone': '972-50-4645474'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Gynecologist and Obstetrician', 'investigatorFullName': 'Dr. Jigal Haas MD', 'investigatorAffiliation': 'Sheba Medical Center'}}}}