Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-03 @ 11:11 PM
Study NCT ID:
NCT02209168
Status:
WITHDRAWN
Last Update Posted:
2018-09-04
First Post:
2014-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differences in Ovarian Reserve Markers and Vitamin D Between Infertile Indian, Arabian and Caucasian Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Vitamine D serum levels.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2014-08-01', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovarian reserve markers: antimullerian hormone, FSH, antral follicle count', 'timeFrame': 'beginning of the treatment cycle'}], 'secondaryOutcomes': [{'measure': 'Serum vitamin D levels', 'timeFrame': 'Beginning of their treatment cycle'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AMH, ACF, VIT D, Ethnicity'], 'conditions': ['Female Infertility Due to Diminished Ovarian Reserve', 'Vitamin D Deficiency', 'Hormone Deficiency', 'Follicular Cyst of Ovary']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to confirm the difference in ovarian reserve markers and serum vitamine D levels between infertile indian, arabian and caucasian population.', 'detailedDescription': '200 caucasian, indian, and arab patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'WOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERTILIZATION TREATMENT DUE TO TUBAL, MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERILIZATION TREATMENT DUE TO TUBAL, MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT\n\nExclusion Criteria:\n\nPOLYCYSTIC PATIENTS ENDOMETRIOSIS GRADE III OR IV INFLAMMATORY PELVIC DISEASE'}, 'identificationModule': {'nctId': 'NCT02209168', 'briefTitle': 'Differences in Ovarian Reserve Markers and Vitamin D Between Infertile Indian, Arabian and Caucasian Population', 'organization': {'class': 'OTHER', 'fullName': 'IVI Madrid'}, 'officialTitle': 'Differences in Ovarian Reserve Markers, Vitamin D Serum Levels and Reproductive Outcomes Between Infertile Indian, Arabian and Caucasian Population', 'orgStudyIdInfo': {'id': '1405-MAD-020-JG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infertile Indian Population', 'description': '200 Infertile Indian population'}, {'label': 'Infertile arabian population', 'description': '200 Infertile Arabian population'}, {'label': 'Infertile caucasian population', 'description': '200 Infertile Caucasian population'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28023', 'city': 'Madrid', 'country': 'Spain', 'facility': 'IVI Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'CARLOS IGLESIAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Carlos Iglesias, MD', 'investigatorFullName': 'Juan A Garcia-Velasco', 'investigatorAffiliation': 'IVI Madrid'}}}}