Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 4:36 PM
Study NCT ID:
NCT04472234
Status:
COMPLETED
Last Update Posted:
2020-07-15
First Post:
2020-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-14', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exposure to BPA', 'timeFrame': '6 month', 'description': 'Concentrations of Bisphenol A (BPA) will be quantified in the ürine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with unexplained infertility'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility Unexplained', 'IVF', 'Infertility, Female']}, 'descriptionModule': {'briefSummary': 'The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '33 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 23-33 years who underwent IVF due to unexplained infertility\n* patients provided urine, blood, and follicle fluid (FF) samples on the oocyte retrieval day\n* patients who did not smoke or use alcohol\n* patients did not work in the plastic industry\n\nExclusion Criteria:\n\n* patients who underwent IVF due to low ovarian reserve or tubal factor or male factor indications\n* patients diagnosed with endometriosis\n* patients with freeze-all cycles\n* women with metabolic disease (such as hypertension or diabetes mellitus)\n* patients with a known genetic problem (male or female)'}, 'identificationModule': {'nctId': 'NCT04472234', 'briefTitle': 'BPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}, 'officialTitle': 'Could the Consumption of Water From Plastic Bottles Affect the Embryo Grade and Clinical Pregnancy Rate Obtained With IVF/ICSI in Unexplained Infertility', 'orgStudyIdInfo': {'id': '2019/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BPA level', 'description': 'BPA (Bisfenol A) in urine, blood and follicle fluid samples', 'interventionNames': ['Other: BPA levels']}], 'interventions': [{'name': 'BPA levels', 'type': 'OTHER', 'description': 'BPA (Bisfenol A) in urine, blood and follicle fluid samples', 'armGroupLabels': ['BPA level']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sanliurfa', 'country': 'Turkey (Türkiye)', 'facility': 'Nefise Nazlı YENIGUL', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nefise Nazlı YENIGUL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ph.D. Assistant Professor Department of Obstetrics and Gynecolog', 'investigatorFullName': 'Nefise Nazlı YENIGUL', 'investigatorAffiliation': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}}}}