IMPROVING COMMUNICATION WITH IVF PATIENTS ABOUT RISKS SUCH AS MULTIPLE BIRTHS

描述（由申请人提供）：本研究的长期目标是提高患者对使用辅助生殖技术（ART）（如体外受精（IVF））治疗不孕症的已知和假设风险的理解。当试管婴儿期间转移到子宫的胚胎较少时，多胎妊娠的机会较低，但这对夫妇可能需要支付更多的治疗周期，以弥补该周期活产的机会较低。虽然许多多胎分娩的健康结果是好的，但这些妊娠有更多的并发症，婴儿患神经系统问题或新生儿死亡的风险更高。没有关于患者理解IVF单胎妊娠并发症和新生儿问题增加的可能性的新科学问题的信息，也没有关于IVF或卵胞浆内单精子注射（ICSI）受孕的儿童可能的表观遗传疾病或遗传性不孕症的信息。试管婴儿的决定可能很难让患者做出，因为不孕的背景痛苦，加上面对科学的不确定性需要权衡复杂的风险-收益权衡。很少有研究可以评估健康素养或计算能力有限的不孕症患者如何做出决定。从癌症研究中调整健康传播方法，我们的具体目标是：1）招募130对夫妇（90人在威奇托，40人在芝加哥）寻求试管婴儿，并收集有关项目的横截面数据，如对单胞胎与双胞胎的偏好，压力源，知识，信仰，健康素养和算术，对不常见或不确定风险信息的偏好，在与IVF和其他因素相关的决策过程中所需的自主权程度。2)在这些夫妇中进行随机对照临床试验，以测试新的教育干预措施的有效性，包括新的书面材料，以支持知情决策和IVF护士15分钟的标准化教学会议。3)在胚胎移植后和体外受精后妊娠评估后，通过结构化访谈从参与者那里收集信息，并通过检查表从医生那里收集信息，以测量可能与移植胚胎数量变化和对教育计划的满意度有关的因素，以及患者信念，知识，偏好和决策冲突的变化。这项研究的结果和未来的相关研究将导致更好的病人教育。通过提供证据支持对具有不同怀孕概率的IVF患者更精确的胚胎移植指南，从而减少多胎妊娠，将改善公共卫生。ART每年在美国产生超过11，000例多胞胎分娩，占所有双胞胎的15%，占所有三胞胎和更高阶多胞胎的44%。新的患者教育材料和教育技术将帮助怀孕的夫妇管理IVF单胎和多胎中增加的妊娠并发症和新生儿问题的风险。这项研究的长期目标是提高患者对体外受精（IVF）治疗不孕症的已知和假设风险的理解。将进行一项临床试验，将标准教育与基于理论的干预进行比较，并为正在权衡试管婴儿期间将较少胚胎转移到子宫的风险和益处的夫妇提供新的患者教育材料。研究结果将有助于加强有关风险的知情同意过程，例如当转移更多胚胎时多胎妊娠。新材料还将帮助怀孕的夫妇管理IVF单胎和多胎中增加的孕产妇和新生儿问题的风险。

DESCRIPTION (provided by applicant): The long-term objective of this research is to improve patient understanding of the known and hypothesized risks from treating infertility with assisted reproductive technologies (ART) such as in vitro fertilization (IVF). The chance of having a multi-fetal pregnancy is lower when fewer embryos are transferred to the uterus during IVF, but the couple may need to pay for more cycles of treatment to compensate for a lower chance of having a live birth from that cycle. While health outcomes are good for many multiple birth deliveries, these pregnancies have more complications and the infants are at higher risk for neurologic problems or neonatal death. There is no information on patient understanding of emerging scientific concerns about the potential for increased pregnancy complications and neonatal problems among IVF singletons, nor on possible epigenetic disorders or inherited infertility in children conceived with IVF or intracytoplasmic sperm injection (ICSI). IVF decisions may be difficult for patients to make because of background distress from being infertile, compounded by the need to weigh complex risk-benefit trade-offs in the face of scientific uncertainty. Little research is available to assess how decisions are made by infertility patients with limited health literacy or numeracy skills. Adapting health communication methods from cancer research, our specific aims are to: 1) Recruit 130 couples (90 in Wichita and 40 in Chicago) seeking IVF and collect cross- sectional data on items such as preference for a singleton vs. twins, stressors, knowledge, beliefs, health literacy and numeracy, preferences for information about uncommon or uncertain risks, the degree of autonomy desired during decision-making related to IVF and other factors. 2) Conduct a randomized controlled clinical trial among these couples to test the effectiveness of a new educational intervention consisting of new written materials to support informed decision-making and a 15-minute standardized teaching session by an IVF nurse. 3) Collect information after embryo transfer and after the post-IVF pregnancy assessment from participants by structured interview and from physicians by a checklist to measure factors that may be related to variability in the number of embryos transferred and satisfaction with the educational program, as well as changes in patient beliefs, knowledge, preferences and decisional conflict. This study's findings and future related research will lead to better patient education. Public health will be improved by providing evidence to support more precise embryo transfer guidelines for IVF patients with different probabilities of becoming pregnant, thereby reducing multi-fetal pregnancies. ART produces more than 11,000 multiple birth deliveries in the United States annually, accounting for 15% of all twins and 44% of all triplet and higher order multiple births. The new patient education materials and educational techniques will help couples who achieve pregnancy to manage risks for increased pregnancy complications and neonatal problems among IVF singletons and multiples. The long-term objective of this research is to improve patient understanding of the known and hypothesized risks from treating infertility with in vitro fertilization (IVF). A clinical trial will be conducted, comparing standard education to a theory-based intervention with new patient education materials for couples who are weighing risks and benefits of transferring fewer embryos to the uterus during IVF. Results will help to enhance the informed consent process regarding risks such as multiple gestation pregnancy when more embryos are transferred. The new materials will also help couples who achieve pregnancy to manage risks for increased maternal and neonatal problems among IVF singletons and multiples.