InfertilityA randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial
Section snippets
Materials and methods
A randomized clinical trial was conducted to evaluate an accelerated treatment strategy for couples with unexplained infertility that consisted of three cycles of clomiphene/IUI and up to six cycles of IVF, compared with a step-wise treatment course of three cycles of clomiphene/IUI, three cycles of gonadotropin/IUI, and up to six cycles of IVF. The study protocol was approved by institutional review boards at the participating institutions. Study participants gave written informed consent. An
Results
Between September 14, 2001 and August 31, 2005, we enrolled 503 couples with unexplained infertility; 247 couples were randomized to a conventional and 256 to an accelerated treatment course (Fig. 1); 493 (98%) couples initiated and 417 (83%) followed the treatment protocol. Nineteen couples were in active treatment as of the closing date of the study. Seventy-nine couples took a break from treatment as follows: 22 couples (11 in each arm) stopped for longer than 6 months but returned to
Discussion
The fast track and standard treatment (FASTT) trial provided the rare opportunity to follow 503 treatment-naïve couples through their entire treatment course, including voluntary hiatuses from care, and to compare two different standardized treatment strategies. In this large randomized controlled trial that compared a conventional treatment paradigm to an accelerated strategy to IVF for infertile couples, it was found that gonadotropin/IUI use was of no added value. Couples in the accelerated
Acknowledgments
We gratefully acknowledge the couples who participated in the trial and the participating insurers Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, and Tufts Health Plan. We thank study research coordinators Allison Diamond, M.P.H., and Rachel Neff, M.P.H., and former REI fellow David Ryley, M.D., for their assistance.
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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.
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.
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.