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

• Published in: Fertility and sterility Vol. 94; no. 3; pp. 888 - 899
• Main Authors: Reindollar, Richard H., Regan, Meredith M., Neumann, Peter J., Levine, Bat-Sheva, Thornton, Kim L., Alper, Michael M., Goldman, Marlene B.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.08.2010; Elsevier
• Subjects: Adult; Biological and medical sciences; Birth control; Calibration; Clinical Protocols - standards; Clomiphene - therapeutic use; FASTT Trial; Female; Fertility Agents, Female - therapeutic use; Gonadotropins - therapeutic use; Gynecology. Andrology. Obstetrics; Health Care Costs; Humans; in vitro fertilization; Infertility - economics; Infertility - therapy; Internal Medicine; intrauterine insemination; Male; Medical sciences; Obstetrics and Gynecology; Ovulation Induction; Pregnancy; Pregnancy Rate; Reproductive Techniques, Assisted - economics; Reproductive Techniques, Assisted - standards; Sterility. Assisted procreation; Time Factors; Unexplained infertility; Young Adult; in vitro fertilization; FASTT Trial; intrauterine insemination; Unexplained infertility; Gynecology; Assisted procreation; Obstetrics; Sterility; Standards; In vitro fertilization embryo transfer; Randomization; Treatment; Uterus; Artificial insemination; Clinical trial; Fast
• ISSN: 0015-0282; 1556-5653; 1556-5653
• DOI: 10.1016/j.fertnstert.2009.04.022

To determine the value of gonadotropin/intrauterine insemination (FSH/IUI) therapy for infertile women aged 21–39 years. Randomized controlled trial. Academic medical center associated with a private infertility center. Couples with unexplained infertility. 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. 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. 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. A randomized clinical trial demonstrated that FSH/IUI treatment was of no added value.