A prospective, randomized, assessor-blind, multicentre study comparing recombinant and urinary follicle stimulating hormone (Puregon versus Metrodin) in in-vitro fertilization

Abstract

Urinary follicle stimulating hormone (FSH) is being used for the treatment of human infertility. Recently, FSH manufactured by means of recombinant DNA technology with a much higher purity (> 99%) has become available. A prospective, randomized, assessor-blind, multicentre (n = 18) study was conducted in infertile women undergoing in-vitro fertilization comparing recombinant FSH (Org 32489, Puregon) and urinary FSH (Metrodin). Eligible subjects were randomized (recombinant versus urinary FSH = 3:2) and pretreated with buserelin for pituitary suppression. FSH was given until three or more follicles with a diameter of at least 17 mm were seen. After oocyte retrieval, fertilization routines were applied according to local procedures. No more than three embryos were replaced. In all, 585 subjects received recombinant FSH and 396 urinary FSH. Significantly more oocytes were retrieved after recombinant FSH treatment (mean adjusted for centre 10.84 versus 8.95, P < 0.0001). Ongoing pregnancy rates per attempt and transfer in the recombinant FSH group were 22.17 and 25.97% respectively, and in the urinary FSH group, 18.22 and 22.02% respectively (not significant). Ongoing pregnancy rates including pregnancies resulting from frozen-thawed embryo cycles were 25.7% for recombinant and 20.4% for urinary FSH (P = 0.05). Compared to urinary FSH, the total dose of FSH was significantly lower with recombinant FSH (2138 versus 2385 IU, P < 0.0001) in a significantly shorter treatment period (10.7 versus 11.3 days, P < 0.0001). No clinically relevant differences between recombinant and urinary FSH were seen with respect to safety variables. It is concluded that recombinant FSH (Puregon) is more effective than urinary FSH in inducing multifollicular development and achieving an ongoing pregnancy.

Efficacy of a combined protocol of urinary and recombinant follicle-stimulating hormone used for ovarian stimulation of patients undergoing ICSI cycle

“…Several comparison studies have shown that recombinant FSH is more effective than urinary FSH (HMG or highly purified FSH) and the absence of LH activity in rFSH does not affect follicular growth [6][7][8].…”

“…Clinical trials have shown that recombinant FSH is effective in terms of number of oocytes retrieved, number of embryos obtained, and total gonadotropin dose needed, without increasing the risk for the ovarian hyperstimulation syndrome (OHSS) [6][7][8]. In addition, recombinant FSH has been shown to be as effective as urinary FSH or hMG with or without GnRH agonists [9][10][11][12].…”

Endocrinology: Nuclear maturity and oocyte morphology after stimulation with highly purified follicle stimulating hormone compared to human menopausal gonadotrophin

“…The present study, however, cannot answer the question as to which component is responsible for the better results in comparison to HMG stimulation. If a low LH and foreign protein content is considered as being favourable, the development of rFSH represents even greater progress (Howies et al, 1994;Out et al, 1995), as rFSH contains absolutely no LH and no protein with an undefined effect.…”

Effect of highly purified urinary follicle-stimulating hormone on oocyte and embryo quality

“…Studies have shown that FSH, even in the absence of LH, induces multiple follicular growth as well as meiotically and developmentally competent oocytes (17), although serum concentrations of estradiol remain lower than levels resulting from follicular stimulation with hMG (29 -33). However, in agreement with our results, recent studies of urinary FSH or hMG and recombinant FSH had similar results in terms of oocyte and embryo quality and of implantation and pregnancy rates (25,26,34).…”

“…Recent clinical trials have shown that recombinant FSH is effective in terms of number of oocytes retrieved, number of embryos obtained, and total gonadotropin dose needed, without increasing the risk for the ovarian hyperstimulation syndrome (OHSS) (17)(18)(19). In addition, recombinant FSH has been shown to be as effective as urinary FSH or hMG (20 -24), with or without GnRH agonists.…”