EAGeR随机试验中的低剂量阿司匹林和散发性无排卵

Rose G. Radin, L. Sjaarda, N. Perkins, R. Silver, Zhen Chen, Laurie L. Lesher, N. Galai, J. Wactawski‐Wende, S. Mumford, E. Schisterman
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引用次数: 12

摘要

在最近一次流产的女性中,每日孕前低剂量阿司匹林(LDA)增加了活产率,但对流产没有影响。排卵是这种影响的潜在机制。目的评估LDA对痛经女性月经周期无排卵风险的影响。设计多中心、随机、双盲、安慰剂对照的每日LDA对生殖结局的影响试验。孕前随访持续1 - 6个月经周期(ClinicalTrials.gov, NCT00467363)。以2007年至2011年期间的四个美国医疗中心为背景。患者或其他参与者健康女性(n = 1214),年龄18 ~ 40岁,尝试怀孕,月经周期规律(21 ~ 42天),有1 ~ 2次有记录的妊娠失败史,≤2次活产,无不孕。所有受试者完成至少1个月经周期的随访;没有人因不良事件退出。干预措施:阿司匹林(81毫克),每日1 - 6个月经周期。主要结果测量指标:每周期无排卵风险,定义为尿样妊娠试验阳性和黄体生成素(LH)峰值(每日尿LH升高2.5倍)均未出现。假设制定先于数据收集。结果在4340个周期中,LDA与无排卵无关(LDA: 13.4%,安慰剂:11.1%;风险比= 1.16,95%可信区间为0.88 ~ 1.52)。在最近一次减肥的女性中,结果也类似。结论每日LDA对有1 ~ 2次流产史的女性无排卵影响。LDA可能通过其他途径影响生育,这些值得进一步研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Low-Dose Aspirin and Sporadic Anovulation in the EAGeR Randomized Trial
Context Among women with a single, recent pregnancy loss, daily preconception low-dose aspirin (LDA) increased the live birth rate with no effect on pregnancy loss. Ovulation is a potential mechanism underlying this effect. Objective We estimated the effect of LDA on the per-cycle risk of anovulation among eumenorrheic women. Design Multicenter, randomized, double-blind, placebo-controlled trial of daily LDA on reproductive outcomes. Preconception follow-up lasted 1 to 6 menstrual cycles (ClinicalTrials.gov, NCT00467363). Setting Four US medical centers during 2007 to 2011. Patients or Other Participants Healthy women (n = 1214), age 18 to 40, were attempting pregnancy, had regular menstrual cycles (21 to 42 days), and had a history of 1 to 2 documented pregnancy losses, ≤2 live births, and no infertility. All participants completed at least 1 menstrual cycle of follow-up; none withdrew due to adverse events. Intervention Aspirin (81 mg) daily for 1 to 6 menstrual cycles. Main Outcome Measure Per-cycle risk of anovulation, defined as the absence of both a positive spot-urine pregnancy test and a luteinizing hormone (LH) peak (2.5-fold increase in daily urinary LH). Hypothesis formulation preceded data collection. Results Among 4340 cycles, LDA was not associated with anovulation (LDA: 13.4%, placebo: 11.1%; risk ratio = 1.16, 95% confidence interval, 0.88 to 1.52). Results were similar among women with a single, recent loss. Conclusions Daily LDA had no effect on anovulation among women with a history of 1 to 2 pregnancy losses. LDA may affect fertility via other pathways, and these warrant further study.
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