When is clomiphene or gonadotropin intrauterine insemination futile? Results of the Fast Track and Standard Treatment Trial and the Forty and Over Treatment Trial, two prospective randomized controlled trials.

ObjectiveTo determine whether day 3 FSH and E2 levels at the upper limits of normal affect live-birth rates and treatment trajectory in a conventional versus "fast track" treatment program for IVF.DesignSecondary analysis of two randomized controlled trials, FASTT and FORT-T.SettingNot applicable.Patient(s)Infertile women ages 21-42 years randomized to conventional or accelerated treatment with controlled ovarian hyperstimulation (COH)-IUI and/or IVF (n=603 patients contributing 2,717 total cycles).Intervention(s)Patients were stratified according to basal FSH and E2: FSH<10 mIU/mL and E2<40 pg/mL (group 1A), FSH<10 mIU/mL and E2≥40 pg/mL (group 1B), FSH, 10-15 mIU/mL and E2<40 pg/mL (group 2A), and FSH, 10-15 mIU/mL and E2≥40 pg/mL (group 2B).Main outcome measure(s)Number of cancelled cycles, disenrollment for poor response, and cumulative live-birth rates per couple.Result(s)Women in groups 2A and 2B were more likely to have cancelled cycles and be disenrolled for poor response. While no live births occurred in group 2B during COH-IUI (0/19 couples, 0/58 cycles), IVF still afforded these patients a reasonable chance of success (6/18 couples, 6/40 cycles, 33.3% live-birth rate per couple). The specificity and positive predictive value of basal FSH of 10-15 mIU/mL and E2≥40 pg/mL for no live birth during COH-IUI treatment were both 100%.Conclusion(s)Women who initiated infertility treatment with FSH of 10-15 mIU/mL and E2≥40 pg/mL on day 3 testing were unlikely to achieve live birth after COH-IUI treatment.