Communication With in Vitro Fertilization (IVF) Patients About Risks
Improving Communication With IVF Patients About Risks Such as Multiple Births
2 other identifiers
interventional
264
1 country
1
Brief Summary
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. Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 23, 2008
CompletedFirst Posted
Study publicly available on registry
July 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedNovember 25, 2016
November 1, 2016
2.4 years
July 23, 2008
November 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
questionnaire assessing knowledge, risk perception, self efficacy and preferences, interview about risk perception and decision making
Prior to IVF treatment cycle, 8 weeks
Secondary Outcomes (1)
Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors
Prior to IVF treatment cycle, 8 weeks
Study Arms (2)
Intervention
ACTIVE COMPARATORWritten materials, telephone based education
Comparison
OTHERWritten materials
Interventions
4 new written materials, 15-20 minute educational session by telephone
Eligibility Criteria
You may qualify if:
- At least 18 years of age
You may not qualify if:
- Using a gestational carrier in the current cycle of IVF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas School of Medicine
Wichita, Kansas, 67214, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Frazier, MD
University of Kansas School of Medicine-Wichita
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2008
First Posted
July 25, 2008
Study Start
September 1, 2007
Primary Completion
February 1, 2010
Study Completion
May 1, 2010
Last Updated
November 25, 2016
Record last verified: 2016-11