Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-30 @ 9:53 PM
Study NCT ID:
NCT04455256
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2020-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2020-06-28', 'studyFirstSubmitQcDate': '2020-06-28', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Show the effect of endoplasmic reticulum stress on recurrent pregnancy loss', 'timeFrame': '3 months', 'description': 'Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Pregnancy Loss', 'Endoplasmic Reticulum Stress']}, 'descriptionModule': {'briefSummary': 'To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Loss of 3 or more pregnancy between the ages of 18 and 45 and women who have given at least 1 healthy birth in the same age group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with three or more miscarriages before 20 th week of gestation\n* had no chronic or acute inflammatory disease\n* used no steroids, anti-inflammatory, or antioxidant medications\n\nExclusion Criteria:\n\n* had inflammatory diseases\n* had systemic disease\n* Anatomical abnormalities, infectious, endocrine, or genetic etiologies'}, 'identificationModule': {'nctId': 'NCT04455256', 'briefTitle': 'Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Endoplasmic Reticulum Stress in Recurrent Pregnancy Loss', 'orgStudyIdInfo': {'id': 'tgk-xbp'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'recurrent pregnancy loss group', 'description': 'Women between the ages of 18 and 45 who had a history of miscarriage under 3 weeks and above 22 weeks were included in this group.', 'interventionNames': ['Other: x box binding protein']}, {'label': 'women who had healthy birth', 'description': 'Women between the ages of 18-45 who have not had a history of pregnancy loss and who have had at least one healthy birth and no known chronic diseases are included in this group.', 'interventionNames': ['Other: x box binding protein']}], 'interventions': [{'name': 'x box binding protein', 'type': 'OTHER', 'description': 'Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.', 'armGroupLabels': ['recurrent pregnancy loss group', 'women who had healthy birth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'İ̇stanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pinar Yalcin Bahat', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pınar Yalcin bahat', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}