Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT05212506
Status:
UNKNOWN
Last Update Posted:
2022-01-28
First Post:
2022-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Analysis of Covid-19 IgG Antibody Level in Seminal Plasma and Semen Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2022-01-27', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'semen index', 'timeFrame': '2022.01-2022.03', 'description': 'the semen index of the participants'}], 'secondaryOutcomes': [{'measure': 'Fertilization rate', 'timeFrame': '2022.01-2022.04', 'description': 'The percentage of eggs fertilized'}, {'measure': 'embryo quality', 'timeFrame': '2022.02-2022.05', 'description': 'Grading of formed embryos'}, {'measure': 'clinical pregnant rate', 'timeFrame': '2022.03-2022.05', 'description': 'after the embryo transplantation, calculate the pregnancy rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid-19', 'IgG Antibody', 'Semen Index']}, 'descriptionModule': {'briefSummary': 'Since December 2019, more and more cases of unexplained pneumonia appeared after exposure to the South China Seafood Market in Wuhan City, Hubei Province. Later, the disease were confirmed to be acute respiratory infectious diseases caused by the 2019 new coronavirus infection.\n\nEven though we have had great victories in the war against this pandemic, there is still a very large number of deaths early on. As research progresses, vaccines for this infectious disease are already being developed. There are currently two vaccines in widespread use worldwide: mRNA vaccines and inactivated vaccines. In China, inactivated vaccines are more commonly used. At present, some studies believe that mRNA vaccine does not affect the pregnancy rate and abortion rate of women, but the study sample size is small, and the conclusions are limited. The effects of inactivated vaccines on fertility are still in the blank. We now hope to conduct prospective studies, mainly to study the effect of inactivated vaccine injection on male semen, and whether it has an effect on the quality of embryos in IVF patients'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The man's semen quality is normal and has been injected covid-19 vaccine", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The man's semen quality is normal,\n2. The couple meets the indications for IVF,\n3. injected with the covid-19 vaccine\n\nExclusion Criteria:\n\n1. In vitro fertilization due to male factors\n2. Azoospermia\n3. The quality of the man's semen is abnormal\n4. unvacced"}, 'identificationModule': {'nctId': 'NCT05212506', 'briefTitle': 'Correlation Analysis of Covid-19 IgG Antibody Level in Seminal Plasma and Semen Index', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'officialTitle': 'Association of Seminal Plasma SARS-Cov19 IgG Level With Semen Parameters and Embryological Characteristics in Vaccinated Normozoospermic Men', 'orgStudyIdInfo': {'id': 'chen008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'vaccinated and unvaccinated', 'interventionNames': ['Biological: vaccinated and unvaccinated']}], 'interventions': [{'name': 'vaccinated and unvaccinated', 'type': 'BIOLOGICAL', 'description': 'the vaccinated :Male patients who received more than 2 injections of the covid-19 vaccine;the unvaccinated :Male patients who did not receive the covid-19 vaccine', 'armGroupLabels': ['vaccinated and unvaccinated']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qiang yan1', 'role': 'CONTACT', 'email': '602172356@qq.com', 'phone': '18205184018'}], 'facility': 'Shanghai First Maternity and Infant Health Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'qiang yan', 'role': 'CONTACT', 'email': '602172356@qq.com', 'phone': '18205184018'}], 'overallOfficials': [{'name': 'zhiqin chen1', 'role': 'STUDY_DIRECTOR', 'affiliation': 'covid-19 vaccine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'chen zhi qin', 'investigatorAffiliation': 'Shanghai First Maternity and Infant Hospital'}}}}