A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial
Received 11 March 2009; received in revised form 7 April 2009; accepted 8 April 2009. published online 16 June 2009. Corrected Proof
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.
aDepartment of Obstetrics and Gynecology, Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
bDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts
cCenter for the Evaluation of Value and Risk in Health, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts
dDepartment of Obstetrics, Gynecology and Reproductive Biology, Division of Reproductive Endocrinology and Infertility, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Boston IVF, Waltham, Massachusetts
eDepartments of Obstetrics and Gynecology and Community and Family Medicine, Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
Reprint requests: Richard Reindollar, M.D., Department of Obstetrics and Gynecology, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756 (FAX: 603-650-0906).
Supported by a grant from the National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland (R01 HD38561). The National Institute of Child Health and Human Development had no role in the design or conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
R.H.R. reports receiving fellowship training funds and lecture fees from Ferring, Organon, and Serono before 2005. M.M.R. has nothing to disclose. P.J.N. reports receiving grant support from Elan Pharmaceuticals and Johnson & Johnson, receiving consultant fees from Serono and General Electric, and serving on advisory boards for Merck, Schering Plough, and Abbott; B-S.L. reports receiving an educational grant from Novo Nordisk. K.L.T. reports receiving fellowship training support from Ferring, research grant support from Duramed, Organon, and Serono, consulting fees from Organon, and lecture fees from Organon and Serono. M.M.A. reports receiving unrestricted research grants from Serono and Organon, consulting fees from Serono, and lecture fees from Ferring, Organon, and Serono. M.B.G. has nothing to disclose.
Presented at the annual meeting of the American Society of Reproductive Medicine, Washington, D.C., October 14–17, 2007.
Work was performed at the Department of Obstetrics and Gynecology and Reproductive Biology, Division of Reproductive Endocrinology and Infertility, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Boston IVF, Waltham, Massachusetts; and the Department of Obstetrics and Gynecology, Dartmouth Medical School, Hanover, New Hampshire.
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