Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
Study NCT ID:
NCT05688995
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2023-01-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 Vaccines and the Menstrual Cycle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 617}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-17', 'studyFirstSubmitDate': '2023-01-17', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'significant changes in the menstrual cycle after vaccination', 'timeFrame': '6 months', 'description': 'changes that involve bleeding amount or pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menstrual Irregularity']}, 'descriptionModule': {'briefSummary': 'The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle', 'detailedDescription': 'This is a descriptive cross-sectional study that took place between September 2021 and December 2021. The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle. It used an anonymous questionnaire distributed via social media platforms; Facebook, Twitter, and WhatsApp across different cities of Jordan. A total of 732 responses were received with a 59% response rate.\n\nThe questionnaire was distributed over four months directed at women who have received at least one dose of the COVID-19 vaccine and who live in Jordan. It took 10 minutes to complete all the questions.\n\nData collection did not involve direct contact with participants to prevent the spread of COVID-19.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Our study included 617 Menstruating females. 74.55% of participants were of the age group between 20-35 years. 59.64% had normal BMI (18.5-24.9 Kg/m2), while 11.99% were underweight (BMI less than 18.5 Kg/m2), 19.77% were overweight (BMI\\>24.9 Kg/m2 but less than 30 Kg/m2), and 8.59% were obese (BMI more than 30 Kg/m2). Largest BMI was 39.79 Kg/m2. Most of participants were single ladies (79.25%). 82.01% were nulliparous. 17.83% were multiparous, including 1.62% ladies that had 5 or more children (grand multiparous).', 'genderDescription': 'women with menstrual cycle', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* less than 40 years\n* healthy women\n* received covid-19 vaccine\n\nExclusion Criteria:\n\n* women who did not receive the vaccine\n* those living outside Jordan (those cannot fill the form) and during analysis.'}, 'identificationModule': {'nctId': 'NCT05688995', 'briefTitle': 'COVID-19 Vaccines and the Menstrual Cycle', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'COVID-19 Vaccines and the Menstrual Cycle; a Cross-sectional Study', 'orgStudyIdInfo': {'id': 'ju'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Naser Al-Husban', 'type': 'BIOLOGICAL', 'description': 'COVID-19 vaccines'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11941', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Jordan University Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Naser U Al-Husban', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Jordan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'can be shared with reasonable request from the primary investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Naser Al-Husban', 'investigatorAffiliation': 'University of Jordan'}}}}