Ignite Creation Date:
2025-12-25 @ 1:59 AM
Ignite Modification Date:
2026-04-21 @ 2:50 PM
Study NCT ID:
NCT02383394
Status:
UNKNOWN
Last Update Posted:
2017-04-05
First Post:
2015-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Pregnancy Loss in IVF Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2015-03-06', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'second trimester abortion', 'timeFrame': 'between 12 1/7 and 23 6/7 weeks of gestation)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['second trimesteric pregnancy loss'], 'conditions': ['Invitro Fertilization']}, 'descriptionModule': {'briefSummary': 'Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.', 'detailedDescription': 'Maternal characteristics as age , parity, body mass index, previous abortion,previous failed IVF cycles, weight gain during pregnancy, physical activity, sexual relation and frequency, adherence to treatment, residency, medical history,surgical pelvic history, fever during pregnancy.\n\nClinical characteristics as multiple pregnancy, site of implantation, day of transfer, serum HCG day 14.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)\n\nExclusion Criteria:\n\n* abnormal uterine cavity induced abortion for medical problem'}, 'identificationModule': {'nctId': 'NCT02383394', 'briefTitle': 'Factors Associated With Pregnancy Loss in IVF Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Factors Associated With Second-Trimester Pregnancy Loss in Women With Normal Uterine Anatomy Undergoing In Vitro Fertilization', 'orgStudyIdInfo': {'id': '131'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'aborted women', 'description': 'women who got pregnant and have 2nd trimesteric abortion, follow up antenatal care by ultrasound and clinical monitoring', 'interventionNames': ['Other: follow up antenatal care']}, {'label': 'continued women', 'description': 'women who got pregnant and completed her pregnancy follow up antenatal care by ultrasound and clinical monitoring', 'interventionNames': ['Other: follow up antenatal care']}], 'interventions': [{'name': 'follow up antenatal care', 'type': 'OTHER', 'description': 'ultrasound follow up of pregnancy', 'armGroupLabels': ['aborted women', 'continued women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT'}, {'name': 'Ahmed Shaker, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ahmed Maged', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed M Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '01005227404'}, {'name': 'Adel Nada, MD', 'role': 'CONTACT', 'email': 'adel.nada29@gmail.com'}], 'overallOfficials': [{'name': 'Ahmed Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy medical school'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}