IMPROVING COMMUNICATION WITH IVF PATIENTS ABOUT RISKS SUCH AS MULTIPLE BIRTHS

描述(由申请人提供)：这项研究的长期目标是提高患者对使用体外受精(IVF)等辅助生殖技术(ART)治疗不孕不育的已知和假设风险的理解。在试管受精过程中，当较少的胚胎被移植到子宫中时，多胎妊娠的可能性较低，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机会较低。虽然许多多胎分娩的健康结果是好的，但这些怀孕有更多的并发症，婴儿出现神经问题或新生儿死亡的风险更高。目前还没有关于患者对新出现的科学问题的理解的信息，这些问题涉及试管婴儿中怀孕并发症和新生儿问题的可能性增加，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障碍或遗传性不孕症的信息。患者可能很难做出试管受精的决定，因为不孕不育的背景痛苦，再加上面对科学不确定性需要权衡复杂的风险和利益权衡。很少有研究可以评估健康素养或算术技能有限的不孕不育患者是如何做出决定的。采用癌症研究中的健康传播方法，我们的具体目标是：1)招募130对寻求试管受精的夫妇(威奇托90对，芝加哥40对)，并收集有关项目的横断面数据，如对单胞胎和双胞胎的偏好、压力源、知识、信念、健康素养和算术、对关于罕见或不确定风险的信息的偏好、在与试管受精相关的决策过程中期望的自主程度和其他因素。2)在这些夫妇中进行随机对照临床试验，以测试新教育干预的有效性，包括支持知情决策的新书面材料和由试管受精护士进行的15分钟标准化教学课程。3)在胚胎移植后和IVF妊娠后评估后，通过结构化访谈从参与者那里收集信息，通过检查表从医生那里收集信息，以衡量可能与移植胚胎数量的变化和对教育计划的满意度相关的因素，以及患者信念、知识、偏好和决策冲突的变化。这项研究的发现和未来的相关研究将导致更好的患者教育。通过提供证据支持对不同怀孕概率的试管婴儿患者进行更精确的胚胎移植指南，从而减少多胎妊娠，将改善公共健康。ART每年在美国生产超过11000个多胞胎，占所有双胞胎的15%，占所有三胞胎及以上多胞胎的44%。新的患者教育材料和教育技术将帮助怀孕的夫妇管理试管受精单胞胎和多胞胎中怀孕并发症和新生儿问题增加的风险。这项研究的长期目标是提高患者对体外受精(IVF)治疗不孕不育的已知和假设风险的理解。将进行一项临床试验，将标准教育与使用新的患者教育材料的基于理论的干预进行比较，这些夫妇正在权衡在试管受精期间将更少的胚胎转移到子宫的风险和好处。结果将有助于加强对风险的知情同意过程，例如当更多的胚胎被移植时，多胎妊娠。新材料还将帮助怀孕的夫妇管理试管受精单胞胎和多胞胎中母亲和新生儿问题增加的风险。

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.