Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-05 @ 6:56 AM
Study NCT ID:
NCT00161395
Status:
COMPLETED
Last Update Posted:
2008-05-16
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Time to Pregnancy in Normal Fertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-14', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2008-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Pregnancy', 'timeFrame': 'Up to one year.'}], 'secondaryOutcomes': [{'measure': 'Distribution of coitus within "fertile" days of menstrual cycle', 'timeFrame': 'Seven menstrual cycles.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fertility', 'pregnancy'], 'conditions': ['Fertility', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '25225008', 'type': 'DERIVED', 'citation': 'Stanford JB, Smith KR, Varner MW. Impact of instruction in the Creighton model fertilitycare system on time to pregnancy in couples of proven fecundity: results of a randomised trial. Paediatr Perinat Epidemiol. 2014 Sep;28(5):391-9. doi: 10.1111/ppe.12141.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.', 'detailedDescription': 'Research has established that there are relatively few days of the menstrual cycle that have a substantial probability of pregnancy from coitus, and that there are prospective biomarkers that allow a woman or couple to identify these "fertile" days. However, it remains unclear how this knowledge may improve a couple\'s chances of conceiving.\n\nAll couples participating in this study must have a history of previous pregnancy together and no history suggesting subfertility. Participants in this study will be randomly assigned to one of two groups. One group will receive instruction about identifying the days when a woman is mostly likely to get pregnant from intercourse, using the Creighton Model FertilityCare System, and the other group will receive instructions about the menstrual cycle, fertility, and preparing for pregnancy. Randomization is stratified by age.\n\nAll participants will keep a daily fertility chart and use a computerized device called the Fertility Monitor with urine dipsticks to monitor hormones of the menstrual cycle.\n\nThe primary outcome is time to pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* couple with prior pregnancy within the past 8 years\n\nExclusion Criteria:\n\n* any history that suggests subfertility\n* any history that suggests a medical contraindication for pregnancy'}, 'identificationModule': {'nctId': 'NCT00161395', 'briefTitle': 'Study of Time to Pregnancy in Normal Fertility', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility', 'orgStudyIdInfo': {'id': 'K23HD001479', 'link': 'https://reporter.nih.gov/quickSearch/K23HD001479', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Preconception advice.', 'interventionNames': ['Behavioral: Preconception advice']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Instruction in the Creighton Model Fertility Care System.', 'interventionNames': ['Behavioral: Instruction in the Creighton Model Fertility Care System']}], 'interventions': [{'name': 'Instruction in the Creighton Model Fertility Care System', 'type': 'BEHAVIORAL', 'otherNames': ['Fertility awareness instruction.'], 'description': 'Instruction in the Creighton Model Fertility Care System.', 'armGroupLabels': ['2']}, {'name': 'Preconception advice', 'type': 'BEHAVIORAL', 'description': 'Preconception advice for diet and frequency of intercourse.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah, Dept. Family and Preventive Medicine', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Joseph B Stanford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Joseph Stanford, M.D., Principal Investigator', 'oldOrganization': 'University of Utah'}}}}