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

Capsule:
Controlled ovarian hyperstimulation with intrauterine insemination may be futile for infertile couples of any age with follicle stimulating hormone levels of 10–15 mIU/mL and estradiol 40 pg/mL.

Authors:
Daniel J. Kaser, M.D., Marlene B. Goldman, Sc.D., June L. Fung, Ph.D., Michael M. Alper, M.D., Richard H. Reindollar, M.D.

Volume 102, Issue 5, Pages 1331–1337.e1

Abstract:

Objective:
To 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.

Design:
Secondary analysis of two randomized controlled trials, FASTT and FORT-T.

Setting:
Multicenter study in a state with mandated insurance coverage.

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.

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