Review of the safety, efficacy, costs and patient acceptability of recombinant follicle-stimulating hormone for injection in assisting ovulation induction in infertile women

Marleen Nahuis, Fulco van der Veen, Jur Oosterhuis, Ben Willem Mol, Peter Hompes, Madelon van Wely, Marleen Nahuis, Fulco van der Veen, Jur Oosterhuis, Ben Willem Mol, Peter Hompes, Madelon van Wely

Abstract

Anovulation is a common cause of female subfertility. Treatment of anovulation is aimed at induction of ovulation. In women with clomiphene-citrate resistant WHO group II anovulation, one of the treatment options is ovulation induction with exogenous follicle-stimulating hormone (FSH or follitropin). FSH is derived from urine or is produced as recombinant FSH. Two forms of recombinant FSH are available - follitropin alpha and follitropin beta. To evaluate the efficacy, safety, costs and acceptability of recombinant FSH, we performed a review to compare recombinant FSH with urinary-derived FSH products. Follitropin alpha, beta and urinary FSH products appeared to be equally effective in terms of pregnancy rates. Patient safety was also found to be comparable, as the incidence of side effects including multiple pregnancies was similar for all FSH products. In practice follitropin alpha and beta may be more convenient to use due to the ease of self-administration, but they are also more expensive than the urinary products.

Keywords: follitropin apha; follitropin beta; polycystic ovary syndrome; urinary gonadotropins.

Figures

Figure 1
Figure 1
The studies’ pooled odds ratios (OR) for pregnancy outcomes and ovulation rate. Abbreviations: rFSH, recombinant follicle-stimulating hormone; uFSH, urinary follicle-stimulating hormone.

References

    1. Hull MG, Glazener CM, Kelly NJ, et al. Population study of causes, treatment, and outcome of infertility. Br Med J (Clin Res Ed) 1985;291:1693–1697.
    1. Gemzell CA, Diczfalusy E, Tillinger G. Clinical effect of human pituitary follicle-stimulating hormone (FSH) J Clin Endocrinol Metab. 1958;18:1333–1348.
    1. Lunenfeld B, Menzi A, Volet B. Clinical effects of a human postmenopausal gonadotropin. Rass Clin Ter. 1960;59:213–216.
    1. Balen AH, Hayden CJ, Rutherford AJ. What are the clinical benefits of recombinant gonadotrophins? Clinical efficacy of recombinant gonadotrophins. Hum Reprod. 1999;14:1411–1417.
    1. Reichl H, Balen A, Jansen CA. Prion transmission in blood and urine: what are the implications for recombinant and urinary-derived gonadotrophins? Hum Reprod. 2002;17:2501–2508.
    1. Shaked GM, Shaked Y, Kariv-Inbal Z, Halimi M, Avraham I, Gabizon R. A protease-resistant prion protein isoform is present in urine of animals and humans affected with prion diseases. J Biol Chem. 2001;276:31479–31482.
    1. Serban A, Legname G, Hansen K, Kovaleva N, Prusiner SB. Immunoglobulins in urine of hamsters with scrapie. J Biol Chem. 2004;279:48817–48820.
    1. Gleicher N, Vietzke M, Vidali A. Bye-bye urinary gonadotrophins? Recombinant FSH: a real progress in ovulation induction and IVF? Hum Reprod. 2003;18:476–482.
    1. Albano C, Smitz J, Camus M, Coelingh Bennink HVSA, Devroey P. Pregnancy and birth in an in vitro fertilisation cycle after controlled ovarian stimulation in a women with a histroy of allergic reactions to human menopausal gonadotropins. Hum Reprod. 1996;11(8):1632–1634.
    1. Hard K, Mekking A, Damm JB, et al. Isolation and structure determination of the intact sialylated N-linked carbohydrate chains of recombinant human follitropin expressed in Chinese hamster ovary cells. Eur J Biochem. 1990;193:263–271.
    1. Barrios-De-Tomasi J, Timossi C, Merchant H, et al. Assessment of the in vitro and in vivo biological activities of the human follicle-stimulating isohormones. Mol Cell Endocrinol. 2002;186:189–198.
    1. Creus S, Chaia Z, Pellizzari EH, Cigorraga SB, Ulloa-Aguirre A, Campo S. Human FSH isoforms: carbohydrate complexity as determinant of in-vitro bioactivity. Mol Cell Endocrinol. 2001;174:41–49.
    1. Ulloa-Aguirre A, Zambrano E, Timossi C, et al. On the nature of the follicle-stimulating signal delivered to the ovary during exogenously controlled follicular maturation. A search into the immunological and biological attributes and the molecular composition of two preparations of urofollitropin Arch Med Res 199526Spec No:S219–S230.
    1. Gordon K. New developments in gonadotrophin pharmacology. Reprod Biomed Online. 2002;5:259–264.
    1. World Health Organisation . WHO manual for the standardized investigation and diagnosis of the infertile couple. Cambridge: Cambridge University Press; 1993.
    1. ESHRE Capri Workshop Group Mono-ovulatory cycles: a key gole in profertility programmes. Hum Reprod Update. 2003;9:263–274.
    1. Rowe PJ, Comhaire FA, Hargreave TB, Mellow HJ. WHO manual for the standardized investigation and diagnosis of the infertile couple. Cambridge: Cambridge University Press. 1997:1–80.
    1. Kousta E, White DM, Piazzi A, Loumaye E, Franks S. Successful induction ovulation and completed pregnancy using recombinant human luteinizing hormone and follicle stimulating hormone in a woman with Kallmann’s syndrome. Hum Reprod. 1996;11:70–71.
    1. Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS) Hum Reprod. 2004;19:41–47.
    1. Homburg R, Howles CM. Low-dose FSH therapy for anovulatory infertility associated with polycystic ovary syndrome: rationale, results, reflections and refinements. Hum Reprod Update. 1999;5:493–499.
    1. Speroff The Clinical Gynecologic Endocrinology and Infertility. 7 ed. 2004. pp. 897–930.
    1. Hugues JN, Cedrin-Durnerin I, Howles CM, et al. The use of a decremental dose regimen in patients treated with a chronic low-dose step-up protocol for WHO Group II anovulation: a prospective randomized multicentre study. Hum Reprod. 2006;21:2817–2822.
    1. Balen AH, Platteau P, Andersen AN, et al. The influence of body weight on response to ovulation induction with gonadotrophins in 335 women with World Health Organization group II anovulatory infertility. BJOG. 2006;113:1195–1202.
    1. van Wely M, Bayram N, van der Veen F. Recombinant FSH in alternative doses or versus urinary gonadotrophins for ovulation induction in subfertility associated with polycystic ovary syndrome: a systematic review based on a Cochrane review. Hum Reprod. 2003;18:1143–1149.
    1. Loumaye E, Martineau I, Piazzi A, et al. Clinical assessment of human gonadotrophins produced by recombinant DNA technology. Hum Reprod. 1996;11(Suppl 1):95–107.
    1. Yarali H, Bukulmez O, Gurgan T. Urinary follicle-stimulating hormone (FSH) versus recombinant FSH in clomiphene citrate-resistant, normogonadotropic,chronic anovulation: a prospective randomized study. Fertil Steril. 1999;72:276–281.
    1. Coelingh Bennink HJ, Fauser BC, Out HJ. Recombinant follicle-stimulating hormone (FSH; Puregon) is more efficient than urinary FSH (Metrodin) in women with clomiphene citrate-resistant, normogonadotropic, chronic anovulation: a prospective, multicenter, assessor-blind, randomized, clinical trial. European Puregon Collaborative Anovulation Study Group. Fertil Steril. 1998;69:19–25.
    1. Balen A, Platteau P, Andersen AN, Devroey P, Helmgaard L, Arce JC. Highly purified FSH is as efficacious as recombinant FSH for ovulation induction in women with WHO Group II anovulatory infertility: a randomized controlled non-inferiority trial. Hum Reprod. 2007;22:1816–1823.
    1. Gerli S, Casini ML, Unfer V, Costabile L, Mignosa M, Di Renzo GC. Ovulation induction with urinary FSH or recombinant FSH in polycystic ovary syndrome patients: a prospective randomized analysis of cost-effectiveness. Reprod Biomed Online. 2004;9:494–499.
    1. Platteau P, Andersen AN, Balen A, et al. Similar ovulation rates, but different follicular development with highly purified menotrophin compared with recombinant FSH in WHO Group II anovulatory infertility: a randomized controlled study. Hum Reprod. 2006;21:1798–1804.
    1. Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle stimulating hormone (r-FSH vs HP-uFSH) in ovulation induction: a prospective, randomized study with cost minimization analysis. Reprod Biol Endocrinol. 2006;18(4):38.
    1. Ricci G, Cerneca F, Simeone R, et al. Impact of highly purified urinary FSH and recombinant FSH on haemostasis: an open-label, randomized, controlled trial. Hum Reprod. 2004;19:838–848.
    1. Szilagyi A, Bartfai G, Manfai A, Koloszar A, Pal A, Szabo I. Low dose ovulation induction with urinary gonadotropins or recombinant follicle stimulating hormone in patients with polycystic ovary syndrome. Gynecol Endocrinol. 2004;18:17–22.
    1. Klip H, Burger CW, Kenemans P, van Leeuwen FE. Cancer risk associated with subfertility and ovulation induction: a review. Cancer Causes Control. 2000;11(4):319–344.
    1. Salhab M, Al Sarakbi W, Mokbel K. In vitro fertilization and breast cancer: a review. Int J Fertil Womens Med. 2005;50(6):259–266.
    1. Weiss N. Gonadotrophin products: empowering patients to choose the product that meets their needs. Reprod Biomed Online. 2007;15(1):31–37.
    1. Somkoti SG, Schertz JC, Moore M, Ferrande L, Kelly E, The gonal-F prefilled pen in OI study 24785 group Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women. Curr Med Res Opin. 2006;22(10):1981–1986.
    1. Aghssa MM, Azargoon A, Ramezanzadeh F, Bagheri M. A comparison of the efficacy, tolerability, and convenience of two formulations of follitropin-alpha in Iranian woman undergoing intracytoplasmic sperm injection cycles. Fertil Steril. 2008;90:1043–1048.
    1. Porter R, Kissel C, Saunders H, Keck C. Patients and nurse evaluation of recombinant follicle stimulating hormone administration methods: a comparison of two follitropin injection pens. Curr Med Res Opin. 2008;24(3):727–735.

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