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. ? ? ?
