alexa A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial.
Reproductive Medicine

Reproductive Medicine

Journal of Fertilization: In Vitro - IVF-Worldwide, Reproductive Medicine, Genetics & Stem Cell Biology

Author(s): Reindollar RH, Regan MM, Neumann PJ, Levine BS, Thornton KL,

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Abstract 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. Copyright (c) 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved. This article was published in Fertil Steril and referenced in Journal of Fertilization: In Vitro - IVF-Worldwide, Reproductive Medicine, Genetics & Stem Cell Biology

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