Is it Possible to Distinguish a Difference in Response Between 200 U and 225 U of Follistim AQ Cartridges in Young Women Undergoing In Vitro Fertilization?

Abstract

BACKGROUND: When the Follistim AQ Cartridge was first introduced, its original manufacturer, Organon, produced pharmacokinetic data to show that their pen device was 18% more efficient at delivering the FSH than at delivering conventional reconstituted lyophilized powder. OBJECTIVE(S): To see whether such small differences in dose could produce a clinically detectable difference in response. MATERIALS AND METHOD(S): Institutional Review Board approval was obtained for this study. The study was designed as a multicenter, prospective, nonblinded, randomized, controlled trial, multicenter trial. One hundred two women under age 35 with FSH <10 and body mass index <30 underwent IVF treatment in five centers. Intracytoplasmic sperm injection was used when appropriate for male factor or medical history. The physicians were given the choice of performing day 3 or day 5 transfers, with an intent to transfer two or fewer embryos, unless medically indicated, but in both cases, a maximum of two embryos were transferred. All women received a 2–3 weeks of oral contraceptives before gonadotropin initiation. On the fifth pill-free day, women were assigned to begin daily injections of 200 IU (group A) or 225 IU (group B) of Follistim AQ, using the pen device. Daily doses of Ganirelix were commenced when the lead follicles were 14 mm. Women were given 5–10,000 IU of hCG when two follicles measured 18 mm. Ovum pickup was performed 35 hours after hCG. P supplementation was left to the discretion of the physicians. Peak E2 levels, egg numbers, and pregnancy rates were compared in both groups. Statistical significance was evaluated with one-way analysis of variance. RESULT(S): Fifty-one women from each group completed treatment. Peak serum E2 levels were similar (group A, 1892 ± 863 pg/mL; group B, 2311 ± 1466 pg/mL, NS, P=.087), as was egg number retrieved (group A, 19 ± 9 eggs; group B, 18.4 ± 9 eggs, NS, P=.78). Clinical pregnancy rates were also similar in both groups (group A = 42%, group B = 41%, NS, P=.934). One woman in group A was hospitalized for severe ovarian hyperstimulation syndrome. CONCLUSION(S): While pharmacokinetic data show Follistim AQ to be 18% more efficient compared with vial forms of FSH, we could not detect a difference in clinical response using slightly different doses of the hormone. However, our results suggest that young, good-prognosis patients undergoing IVF can successfully use 200 IU of Follistim AQ at a considerable financial savings.