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

Objective: To determine whether day 3 FSH and E-2 levels at the upper limits of normal affect live- birth rates and treatment trajectory in a conventional versus fast track'' treatment program for IVF. Design: Secondary analysis of two randomized controlled trials, FASTT and FORT-T. Setting: Not 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 E-2: FSH <10 mIU/mL and E-2 <40 pg/mL (group 1A), FSH <10 mIU/mL and E-2 >= 40 pg/mL (group 1B), FSH, 10-15 mIU/mL and E-2 <40 pg/mL (group 2A), and FSH, 10-15 mIU/mL and E-2 >= 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 E-2 >= 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 E-2 >= 40 pg/mL on day 3 testing were unlikely to achieve live birth after COH-IUI treatment. (C) 2014 by American Society for Reproductive Medicine.