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Gonadotropin-stimulated artificial insemination conventionally precedes in vitro fertilization for couples with unexplained infertility of >12 months' duration who fail to conceive with simpler therapies. However, gonadotropin stimulation is associated with high incidence of multiple pregnancies. Investigators in Boston conducted a trial in which 503 couples were randomized to conventional treatment (≤3 cycles of clomiphene citrate and intrauterine insemination [CC/IUI] followed by ≤3 cycles of follicle-stimulating hormone and IUI [FSH/IUI] and then ≤6 IVF cycles) or to accelerated treatment (≤3 CC/IUI cycles followed by ≤6 IVF cycles).
The percentage of women who delivered at least one baby by the end of the study was similar in both groups (64% overall). Per-cycle pregnancy rates for CC/IUI, FSH/IUI, and IVF were 7.6%, 9.8%, and 30.7%, respectively. However, couples achieved pregnancies in a mean of 8 months in the accelerated arm and in a mean of 11 months in the conventional arm. Rates of multiple births did not differ in the two arms (22%). Insurance charge data (collected for 448 couples) indicated that mean charges per delivery were US$9800 lower in the accelerated arm, with a mean savings of $2600 per couple.
Reindollar RH et al. A randomized clinical trial to evaluate optimal treatment for unexplained infertility: The fast track and standard treatment (FASTT) trial. Fertil Steril 2009 Jun 16; [e-pub ahead of print]. (http://dx.doi.org/10.1016/j.fertnstert.2009.04.022)
Comment
The results of this important trial should guide clinicians who care for infertile couples. Pregnancy rates with CC/IUI and FSH/IUI differed little and were similar to those previously reported; however, the authors note in their discussion that risk for multiple births was much greater with FSH/IUI than with CC/IUI. In terms of both safety and cost, these data make clear that proceeding directly to IVF if CC/IUI fails after 3 cycles is a reasonable strategy. Given continuing improvements in IVF success rates, risk for multiple births should drop further, particularly with accelerated treatment. The investigators note that the study's low dropout rate was related to insurance coverage for infertility in Massachusetts, and they suggest that such coverage should be provided nationwide.