A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial
A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial
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DOI：
10.1016/j.fertnstert.2009.04.022
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发表时间：
2010-08-01
影响因子：
6.7
通讯作者：
Goldman, Marlene B.
中科院分区：
文献类型：
--
作者：
Reindollar, Richard H.;Regan, Meredith M.;Goldman, Marlene B.
目的：确定促性腺激素/宫腔内人工授精（FSH/IUI）治疗21-39岁不孕妇女的价值。设计：随机对照试验。设置：与私人不孕中心相关的学术医疗中心。患者：不明原因不孕夫妇。干预：夫妇被随机接受常规治疗（n = 247），包括3个周期的克罗米芬（CC）/IUI，3个周期的FSH/IUI，以及最多6个周期的IVF或省略3个周期FSH/IUI的加速治疗（n 256）。主要结局指标：建立一个导致活产和成本效益的怀孕所花费的时间，定义为随机化和分娩之间的所有健康保险费用之和除以至少分娩一个活胎的夫妇数量的比率，结果：与常规组相比，加速组的妊娠率增加（风险比[HR]，1.25; 95%置信区间[CI]，1.00-1.56）。加速组和常规组的中位妊娠时间分别为8个月和11个月。CC/IUI、FSH/IUI和IVF的每周期妊娠率分别为7.6%、9.8%和30.7%。与常规治疗相比，加速组每次分娩的平均费用低9，800美元（95% CI，低25，100美元至高3，900美元）。观察到的增量差异是每对夫妇加速治疗节省$2，624，并多分娩0.06次。结论：一项随机临床试验表明，FSH/IUI治疗没有附加值。（Fertil Steril（R）2010; 94：888-99. (c)美国生殖医学会（American Society for Reproductive Medicine）
Objective: To determine the value of gonadotropin/ intrauterine insemination (FSH/IUI) therapy for infertile women aged 21-39 years.Design: Randomized controlled trial.Setting: Academic medical center associated with a private infertility center.Patient(s): Couples with unexplained infertility.Intervention(s): Couples were randomized to receive either conventional treatment (n = 247) with three cycles of clomiphene citrate (CC)/IUI, three cycles of FSH/IUI, and up to six cycles of IVF or an accelerated treatment (n 256) that omitted the three cycles of FSH/IUI.Main Outcome Measure(s): The time it took to establish a pregnancy that led to a live birth and cost-effectiveness, defined as the ratio of the sum of all health insurance charges between randomization and delivery divided by the number of couples delivering at least one live-born baby.Result(s): An increased rate of pregnancy was observed in the accelerated arm (hazard ratio [HR], 1.25; 95% confidence interval [CI], 1.00-1.56) compared with the conventional arm. Median time to pregnancy was 8 and 11 months in the accelerated and conventional arms, respectively. Per cycle pregnancy rates for CC/IUI, FSH/IUI, and IVF were 7.6%, 9.8%, and 30.7%, respectively. Average charges per delivery were $9,800 lower (95% CI, $25,100 lower to $3,900 higher) in the accelerated arm compared to conventional treatment. The observed incremental difference was a savings of $2,624 per couple for accelerated treatment and 0.06 more deliveries.Conclusion(s): A randomized clinical trial demonstrated that FSH/IUI treatment was of no added value. (Fertil Steril (R) 2010; 94: 888-99. (c) 2010 by American Society for Reproductive Medicine.)