Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-18 @ 2:00 AM
Study NCT ID:
NCT01404858
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2011-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome
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': 12800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2011-07-27', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Pregnancy Rates', 'timeFrame': 'Approximately 28 days (1 IVF cycle)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IVF', 'Lifestyle habits'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical and demographic information on the patients who are undergoing treatment at these centers. Information on every aspect of each cycle is also electronically collected daily during each cycle. Demographic and lifestyle information will be collected on all patients prior to cycle start and lifestyle habit information will be collected each time a patient logs onto the patient portal, which averages every few days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women undergoing IVF at a infertility clinic who uses eIVF, an electronic medical record collection entity specifically for IVF patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible patients include, any patient whose:\n\n* infertility clinic uses eIVF\n* is scheduled to undergo an IVF cycle\n* has access to the internet on a daily basis\n* can read and understand English\n* logs onto the patient portal on eIVF'}, 'identificationModule': {'nctId': 'NCT01404858', 'briefTitle': 'The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Boston IVF'}, 'officialTitle': 'The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome', 'orgStudyIdInfo': {'id': 'DC2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing IVF', 'interventionNames': ['Behavioral: There is no intervention; this is a survey only study']}], 'interventions': [{'name': 'There is no intervention; this is a survey only study', 'type': 'BEHAVIORAL', 'description': 'There is no intervention; this is a survey only study', 'armGroupLabels': ['Patients undergoing IVF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston IVF', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}], 'overallOfficials': [{'name': 'Alice D Domar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston IVF'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston IVF', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Alice D. Domar, PhD', 'investigatorFullName': 'Alice D. Domar, PhD', 'investigatorAffiliation': 'Boston IVF'}}}}