Evaluating Optimal Treatment for Unexplained Infertility

The Fast Track & Standard Treatment (FASTT) Trial

What is it and why is it significant?

This research was present at the annual meeting of the American Society of Reproductive Medicine in Washington, D.C. in 2007. The study’s objective is to determine the value of gonadotropin/intrauterine insemination (FSH/IUI) therapy for infertile women aged 21-39 years. For couples with unexplained infertility, the female partner over 40 years, an accelerated track to IVF will result in a shorter time to pregnancy and possibly save in costs compared to conventional care. This study is designed to compare the time to pregnancy and health care costs as well as the success.

Materials & Interventions

How time and money was calculated

A randomized clinical trial was conducted to evaluate an accelerated treatment strategy for couples with unexplained infertility. The trial consisted of 3 cycles of clomiphene/IUI and up to 6 cycles of IVF compared with a step by step treatment course of 3 cycles of clomiphene/IUI, 3 cycles of gonadotropin/IUI, and up to 6 cycles of IVF. The time to pregnancy was calculated from the date of randomization to the date a pregnancy resulting in a live birth was established. Charge data were obtained from participating health insurers, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, and Tufts Health Plan. Charges included physical or health professional time, medications, medical equipment, diagnostic tests, infertility treatments, care of complication, hospitalizations, and delivery/post delivery care. Patients were also asked to keep receipts for expenses such as copayments for prescriptions or visits to therapists or psychiatrists. They were also asked to record transportation costs and the amount of work the couple missed for treatments.

Results & Conclusion

Is there any added value?

503 couples with unexplained fertility were enrolled between September 2001 and August 2005. 247 couples were randomized to a conventional and 256 to an accelerated treatment course. An increased rate of pregnancy was observed in the accelerated compared to the conventional treatment. The average time to pregnancy was 8 to 11 months in the accelerated and conventional arms, respectively. Pregnancy rates for CC/IUI were 7.6%, FSH/IUI were 9.8%, and IVF were 30.7%. The mean charges for delivery were $9,800 lower in the accelerated arm compared to conventional treatment. The gradual difference was a savings of $2,624 per couple for accelerated treatment and 0.06 more deliveries.

Overall, the randomized clinical trial demonstrated that FSH/IUI treatment was of no added value. Couples in the accelerated arm became pregnant at a faster rate, with fewer treatment cycles. If you compare the conventional treatment with the accelerated, you’ll find that the accelerated treatment saves money and results in a greater proportion of couples with delivery of a live-born baby. The charges were also less for couples in the accelerated compared with the conventional. In summary, the results show that contemporary infertility treatments are highly successful today. The majority of couples with unexplained infertility in Massachusetts requiring insurance coverage will most likely succeed. For couples without insurance coverage, this information should hopefully provide guidance for a cost-effective and safe approach to treatment.