Communication With in Vitro Fertilization (IVF) Patients About Risks
Improving Communication With IVF Patients About Risks Such as Multiple Births
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
研究概览
详细说明
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.
Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Kansas
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Wichita、Kansas、美国、67214
- University of Kansas School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- At least 18 years of age
Exclusion Criteria:
- Using a gestational carrier in the current cycle of IVF
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Intervention
Written materials, telephone based education
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4 new written materials, 15-20 minute educational session by telephone
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|
其他：Comparison
Written materials
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2 written materials available on public website
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
questionnaire assessing knowledge, risk perception, self efficacy and preferences, interview about risk perception and decision making
大体时间：Prior to IVF treatment cycle, 8 weeks
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Prior to IVF treatment cycle, 8 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors
大体时间：Prior to IVF treatment cycle, 8 weeks
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Prior to IVF treatment cycle, 8 weeks
|
合作者和调查者
调查人员
- 首席研究员：Linda Frazier, MD、University of Kansas School of Medicine-Wichita
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.