The EAGeR Study is a multi-site, prospective, double-blind, block-randomized trial designed to assess the effects of low-dose aspirin on implantation and pregnancy outcomes. In this trial, 1,228 regularly menstruating women aged 18-40 years with a history of one or two miscarriages and attempting pregnancy again were block-randomized to receive either daily low dose aspirin (81mg) or placebo. Treatment or placebo began before conception and continued for 6 months of trying or through week 36 of pregnancy among women who became pregnant. Participants were stratified into two groups: 1) original: women with one documented pregnancy loss at <20 weeks gestation during the past 12 months; and 2) expanded: women with 1-2 prior pregnancy losses, regardless of gestational age of the loss or time since the loss. Women used fertility monitors to time intercourse and used home pregnancy tests to detect pregnancy. Primary outcomes of the EAGeR trial were published in 2014 (Schisterman et al. Lancet 2014), with additional secondary outcomes published in 2015-2017. Overall, daily low-dose aspirin was not found to prevent subsequent pregnancy loss among women with a history of 1-2 prior losses (Schisterman et al. Lancet 2014; Mumford et al. Human Reproduction 2016). Recently, we found that low-grade inflammation, which was common among non-obese reproductive age women (Sjaarda et al. Paediatr Perinat Epidemiol 2018), was associated with a longer time-to-pregnancy, not through an effect on ovulation but possibly through adiposity (Radin et al. Hum Reprod 2018). We also evaluated vitamin D in relation with androgens, suggesting its potential role on bioavailability of androgens in fecund women (Kuhr et al. Am J Obstet Gynecol 2018). Importantly, we found that sufficient levels of preconception serum vitamin D were associated with increased likelihood of pregnancy and live birth (Mumford et al. Lancet Diabetes Endocrinol 2018), highlighting the potential benefits of preconception vitamin D status in achieving and maintaining healthy pregnancy among women who previously had pregnancy loss. We further observed that modifiable lifestyle factors, including physical activity (Russo et al. Hum Reprod 2018), diet (Kim et al. Am J Epidemiol 2018), weight change (Radin et al. BJOG 2018), and blood pressure (Nobles et al. Hypertension 2018), could play an important role for fecundability as well as healthy pregnancy outcomes in this cohort of women. Investigators are also performing a pilot study under the Human Placental Project using EAGeR serum and urine samples to test a laboratory protocol for measuring placental exosomal miRNA (in collaboration with NCI). The team continues to build upon current findings from EAGeR to fill research gaps and find intervenable means to improve female fecundability for women trying to become pregnant.
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