Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT05489367
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2022-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?
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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'targetDuration': '8 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2022-01-30', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovarian reserve tests and fertility status of 74 women before and after vaccination', 'timeFrame': '6 months after receiving the 2nd dose of vaccine', 'description': 'before and after vaccination serum Amh level ng/ml'}], 'secondaryOutcomes': [{'measure': 'AMH difference between vaccinated and unvaccinated groups', 'timeFrame': '6 months', 'description': 'AMH difference between vaccinated and unvaccinated groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['ovarian reserve', 'covid-19', 'vaccine'], 'conditions': ['COVID-19 Virus Infection', 'Ovarian Function Insufficiency', 'Fertility Disorders', 'Vaccine Adverse Reaction']}, 'descriptionModule': {'briefSummary': "Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination", 'detailedDescription': 'our study ıs desıgned as an observatıonal clınıcal study. the purpose ıs to compare the over reserve tests of the patıents before and after vaccıne, to determıne ıf the over reserve and fertılıty of women are affected by the vaccıne.women who applied to the vaccination outpatient clinic for the first dose of vaccine were included in the study.those who have never been vaccinated and have not had covid 19 infection were included in the study.antı ullerıan hormone level ıs the laboratory parameters that best showıng the ovary reserve today. ovarian reserve tests including amh were checked and their fertility was questioned and their information was recorded.\n\nthe same tests were repeated after the volunteers received 2 doses of vaccine. ın the power analysis, it was calculated that 104 volunteers should be included in the study.the study will be terminated when 104 volunteers are reached.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '74 ovulatory women who were not vaccinated with Biontech.', 'genderDescription': 'volunteers with functional ovaries and female gender', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18-45 years old\n* have ever had a covid vaccine\n* not be infected with covid 19\n\nExclusion Criteria:\n\n* pregnancy\n* diagnosis of any kind of cancer\n* oral contraceptive usage\n* endometrioma\n* PCOS\n* menopause\n* menstrual irregularity\n* premature ovarian insufficiency'}, 'identificationModule': {'nctId': 'NCT05489367', 'briefTitle': 'Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?', 'orgStudyIdInfo': {'id': 'GaziosmanpasaTREHm'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-vaccine ovarian reserve and fertility status', 'description': 'Before vaccination, ovarian reserve tests and fertility status of 64 women will be examined and results will be recorded.After 2 doses of vaccination, ovarian reserve and fertility status of same 64 women will be examined and results will be recorded', 'interventionNames': ['Biological: sars cov 2 biontec vaccine']}], 'interventions': [{'name': 'sars cov 2 biontec vaccine', 'type': 'BIOLOGICAL', 'description': 'volunteers will be expected to receive 2 doses of vaccine', 'armGroupLabels': ['Pre-vaccine ovarian reserve and fertility status']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32225', 'city': 'Istanbul', 'state': 'Gaziosmanpaşa', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpasa Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'A number will be given to each volunteer who agrees to participate in the study.All data obtained will be recorded in this number and all data will be stored on the personal computer of the researcher.No personal data will be shared with anyone other than the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DOCTOR', 'investigatorFullName': 'Elif Yıldız', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}