Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT00722618
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2008-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Communication With in Vitro Fertilization (IVF) Patients About Risks
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-22', 'studyFirstSubmitDate': '2008-07-23', 'studyFirstSubmitQcDate': '2008-07-24', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'questionnaire assessing knowledge, risk perception, self efficacy and preferences, interview about risk perception and decision making', 'timeFrame': 'Prior to IVF treatment cycle, 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors', 'timeFrame': 'Prior to IVF treatment cycle, 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infertility'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': "The primary objective of this trial is to determine whether written educational materials plus brief education by telephone will help patients better understand and participate in the decision on how many embryos to transfer to the uterus during treatment of infertility with in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the study's educational intervention will experience favorable changes in knowledge and beliefs about benefits, susceptibility and severity of multiple gestation that impact decisions about the number of embryos to transfer. Secondary objectives are to understand patient beliefs, knowledge and information preferences regarding other possible risks of IVF, to compare perception of IVF-related risks to familiar risks that are included in routine preconception health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical risks when they make the transition to prenatal care after becoming pregnant.\n\nMedical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment", 'detailedDescription': 'The long-term objective of this research is to improve patient understanding of the known and strongly suspected risks from treating infertility with assisted reproductive technologies such as in vitro fertilization (IVF). During IVF, when more embryos are transferred to the uterus, the risk of pregnancy with multiple fetuses increases. In addition, single infants conceived with IVF are at greater risk for low birth weight. This study will promote behaviors that may reduce these risks. One in 3 women who completes a pregnancy conceived with assisted reproductive technologies such as IVF delivers multiples, and these treatments produce over 12,000 multiple birth deliveries annually in the United States. This study will lead to a better understanding of the most effective ways to counsel IVF patients about the embryo transfer decision. This study will also help define how to prepare IVF patients to work most effectively with their prenatal care team to manage IVF-related obstetrical risks.\n\nMedical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n\nExclusion Criteria:\n\n* Using a gestational carrier in the current cycle of IVF'}, 'identificationModule': {'nctId': 'NCT00722618', 'briefTitle': 'Communication With in Vitro Fertilization (IVF) Patients About Risks', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Improving Communication With IVF Patients About Risks Such as Multiple Births', 'orgStudyIdInfo': {'id': '220060957'}, 'secondaryIdInfos': [{'id': '1R21HD053459-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD053459-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Written materials, telephone based education', 'interventionNames': ['Behavioral: Written materials, telephone based education']}, {'type': 'OTHER', 'label': 'Comparison', 'description': 'Written materials', 'interventionNames': ['Other: Written materials']}], 'interventions': [{'name': 'Written materials, telephone based education', 'type': 'BEHAVIORAL', 'description': '4 new written materials, 15-20 minute educational session by telephone', 'armGroupLabels': ['Intervention']}, {'name': 'Written materials', 'type': 'OTHER', 'description': '2 written materials available on public website', 'armGroupLabels': ['Comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas School of Medicine', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}], 'overallOfficials': [{'name': 'Linda Frazier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas School of Medicine-Wichita'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}