Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT05244967
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2022-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 533}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2022-01-27', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of young women with STIs', 'timeFrame': 'at enrollment', 'description': 'longitudinal analysis of STIs and the female genital tract microbiome'}, {'measure': 'monitoring of STIs and their impact on infertility', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'obtain a better understanding for the emergence of infectious infertility and the impact on the pathogenicity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexually Transmitted Infection']}, 'descriptionModule': {'briefSummary': 'A longitudinal study to investigate the prevalence of sexually transmitted infections among young women and determine the role of the female genital tract microbiome in fertility'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '22 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young women aged 18-22 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-22 years\n* informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* sterilization\n* not capable of giving informed consent'}, 'identificationModule': {'nctId': 'NCT05244967', 'acronym': 'ESTIMATE', 'briefTitle': 'Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility', 'orgStudyIdInfo': {'id': '20-022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'vaginal swab', 'type': 'OTHER', 'description': 'self-sampling, vaginal swab'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nadja Käding', 'role': 'CONTACT'}], 'facility': 'Klinik für Infektiologie und Mikrobiologie', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'centralContacts': [{'name': 'Nadja Käding, Dr.', 'role': 'CONTACT', 'email': 'nadja.kaeding@uksh.de', 'phone': '+4945131019010'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Nadja Käding', 'investigatorAffiliation': 'University of Luebeck'}}}}