Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT02351193
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Predictive Scheme for Poor Responders in IVF Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 928}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-30', 'studyFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of MII oocytes', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'While practicing the different assisted reproductive techniques, the investigators are faced daily by the problem of poor responder females, and the debate about predicting its results based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for ovarian response, the need to re-assess its role was essential in our community, which led us to conduct this prospective multi-center IVF study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Poor responder females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal body mass index (BMI)\n* AMH from 0.5-1.1 ng/ml.\n* previous history of ≤3 oocytes retrieved using conventional long stimulation protocol\n\nExclusion Criteria:\n\n* Females suffering from other causes of infertility as tubal, uterine factors or known cases of endometriosis\n* severe cases of male factor as azospermia\n* females who were unable or not willing to participate in the study were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT02351193', 'briefTitle': 'a Predictive Scheme for Poor Responders in IVF Cycles', 'organization': {'class': 'OTHER', 'fullName': "Woman's Health University Hospital, Egypt"}, 'officialTitle': 'A Predictive Scheme to Assess the Outcome of IVF/ICSI Cycles in Poor Responders. an Observational Study in Egypt', 'orgStudyIdInfo': {'id': '26012015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'poor responder females with age less than 35', 'interventionNames': ['Other: transvaginal Ultrasound']}, {'label': 'Group II', 'description': 'poor responder females with age more than 35', 'interventionNames': ['Other: transvaginal Ultrasound']}], 'interventions': [{'name': 'transvaginal Ultrasound', 'type': 'OTHER', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Kasr el aini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dina MR Dakhly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dina Mohamed Refaat Dakhly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology', 'investigatorFullName': 'Dina Mohamed Refaat Dakhly', 'investigatorAffiliation': "Woman's Health University Hospital, Egypt"}}}}