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。在体外受精过程中，如果将更少的胚胎移植到子宫，多胎妊娠的几率就会降低，但这对夫妇可能需要支付更多周期的治疗费用，以弥补在该周期中获得活产的几率较低。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，婴儿患神经系统疾病或新生儿死亡的风险更高。目前还没有关于患者对试管婴儿单胎妊娠并发症和新生儿问题潜在增加的科学关注的信息，也没有关于试管婴儿或卵胞浆内单精子注射（ICSI）受孕的儿童可能出现的表观遗传疾病或遗传性不孕症的信息。由于不孕背景的困扰，再加上面对科学上的不确定性，需要权衡复杂的风险-收益权衡，患者可能很难做出试管婴儿的决定。很少有研究可以评估健康知识或计算能力有限的不孕症患者如何做出决定。采用癌症研究的健康沟通方法，我们的具体目标是：1)招募130对寻求试管婴儿的夫妇（90对在威奇托，40对在芝加哥），并收集关于单胎与双胞胎偏好、压力源、知识、信仰、健康素养和计算能力、对不常见或不确定风险信息的偏好、在试管婴儿相关决策过程中期望的自主程度和其他因素的横截面数据。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，该干预措施包括新的书面材料，以支持知情决策，并由试管婴儿护士进行15分钟的标准化教学。3)通过结构化访谈的方式收集胚胎移植后和体外受精后妊娠评估后的信息，通过检查表向医生收集信息，测量可能与移植胚胎数量和教育方案满意度变化相关的因素，以及患者信念、知识、偏好和决策冲突的变化。本研究的发现和未来的相关研究将有助于更好地对患者进行教育。通过提供证据，为不同怀孕概率的试管婴儿患者提供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。在美国，ART每年导致超过11000例多胎分娩，占所有双胞胎的15%，占所有三胞胎和更高顺序多胎分娩的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单胎和多胎妊娠并发症和新生儿问题增加的风险。本研究的长期目标是提高患者对体外受精（IVF）治疗不孕症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更少的胚胎移植到子宫的风险和收益的夫妇提供新的患者教育材料。结果将有助于加强知情同意程序的风险，如多胎妊娠时，更多的胚胎移植。新材料还将帮助怀孕的夫妇管理试管受精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.