Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-30 @ 4:08 PM
Study NCT ID:
NCT01139593
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2010-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Comparing Qam With Qpm Dosing in Assisted Reproductive Technologies (ART)
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2010-06-06', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IVF', 'ICSI', 'gonadotropin', 'am dose', 'pm dose', 'pregnancy', 'implantation', 'live birth'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI when taking their gonadotropin dosage in the morning (am) or evening (pm).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infertile women between 21 and 44 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women between 21-42 undergoing IVF\n\nExclusion Criteria:\n\n* women \\> 45,\n* women with one ovary,\n* donor egg,\n* surrogacy,\n* FET cycles,\n* uterine problems,\n* large fibroids'}, 'identificationModule': {'nctId': 'NCT01139593', 'briefTitle': 'A Trial Comparing Qam With Qpm Dosing in Assisted Reproductive Technologies (ART)', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Center for Reproductive Medicine'}, 'officialTitle': 'A Prospective Randomized Trial Comparing Qam With Qpm Daily Dosing in Assisted Reproductive Technologies', 'orgStudyIdInfo': {'id': 'VCRM 5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'morning dose', 'description': 'women undergoing IVF/ICSi taking their gonadotropin dose in the am'}, {'label': 'evening dose', 'description': 'Women undergoing IVF/ICSI taking their gonadotropin in the evening'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20190', 'city': 'Reston', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Center for Reproductive Medicine', 'geoPoint': {'lat': 38.96872, 'lon': -77.3411}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Center for Reproductive Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Fady I. Sharara, M.D', 'investigatorAffiliation': 'Virginia Center for Reproductive Medicine'}}}}