Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 7:14 PM
Study NCT ID:
NCT05347433
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2022-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Fetal Thymus Volumes of Pregnant Women With In Vitro Fertilization (IVF) and Spontaneous Pregnant Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of fetal thymus volume', 'timeFrame': '18-24 week pregnant women', 'description': 'The thymus is located at the superior part of the fetal rib cage. When the transverse section, which includes three vessel images (Superior Vena Cava, Aorta, Pulmonary Artery) is taken, fetal sternum is observed between the three-vessel view and fetal lungs. It is found as a hypoechoic two-lobe structure in the anterior mediastinum compared to other tissues. The fetal thymus dimensions were evaluated by one single person by using the VOLUSON E-10 ultrasonography, which can make VOCAL measurements with 2D and 3D VOCAL Program in 3-vessel trachea sections.'}], 'secondaryOutcomes': [{'measure': 'frequency of pregnancy complications', 'timeFrame': 'during pregnancy and at delivery week', 'description': 'The cases were followed up during pregnancy and at delivery week, and frequency of preeclampsia, non-reliable fetal status, Intrauterine growth restriction and neonatal intensive care requirement wererecorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fetal thymus volume', 'In vitro fertilization'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to compare the fetal thymus volumes of 18-24-week pregnant women with In Vitro Fertilization (IVF) and spontaneous pregnant women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study group consisted of normal pregnant women who applied to the pregnancy clinic for routine pregnancy follow-ups', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* pregnant between 18-24 weeks\n* had no complaints\n* between the ages of 18-35\n* conceived with in vitro fertilization or spontaneously\n\nExclusion Criteria:\n\n* history of endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), systemic diseases (e.g. asthma), collagen disorder, hypercholesterolemia, sickle cell anemia, or neoplasm,\n* those who had a history of coronary artery disease, angina, or myocardial infarction, or a history of hypertension, coronary arteritis, and electrocardiographic changes that suggest any known history of vascular, infectious, or inflammatory disease, maternal autoimmune disease,\n* use of any drugs other than those used for IVF (e.g. insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, and corticosteroids) in the 3 months before the pregnancy,\n* multiple pregnancy,\n* present cigarette and alcohol use,\n* abnormal renal, hepatic, and thyroid function test results;\n* refusing to participate in the study,\n* abnormal fetal findings (fetal anomaly, increased nape transparency, first-second trimester screening test disorder),\n* cases who did not meet the criteria for pregnancy after the first tube treatment (ICSI-ET) because of normoresponder, unexplained infertility, or male factor"}, 'identificationModule': {'nctId': 'NCT05347433', 'briefTitle': 'Comparison of Fetal Thymus Volumes of Pregnant Women With In Vitro Fertilization (IVF) and Spontaneous Pregnant Women.', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Comparison of 18-24 Week Pregnant Women With in Vitro Fertilization (IVF) and Pregnant Women With Spontaneous Pregnancy in the Same Week in Terms of Fetal Thymus Volume', 'orgStudyIdInfo': {'id': '2019/205'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tube baby pregnancy group', 'description': '18-24-week pregnant women with in vitro fertilization'}, {'label': 'Spontaneous pregnancy group', 'description': '18-24-week pregnant women with spontaneous'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Karadeniz Technical University', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Nurgül Selin KAYA', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}