Human follicle-stimulating hormone produced by recombinant DNA technology: a review for clinicians.
Human follicle-stimulating hormone (FSH) is now produced in vitro by recombinant DNA technology. FSH being a complex heterodimeric protein, a eukaryotic cell line has been selected for expression work (Chinese hamster ovary cells). The pharmaceutical preparation of recombinant human FSH (r-FSH) differs from that of human menopausal gonadotrophin (HMG) and the first generation of urinary human FSH (u-FSH) in terms of (i) source of bulk materials, (ii) purity and specific activity, (iii) batch to batch consistency, and (iv) complete absence of luteinizing hormone (LH) activity. Pharmacokinetic characterization of r-FSH has shown an absolute bioavailability of approximately 75% after both s.c. and i.m. administration and an apparent terminal half-life of 37 +/- 25 h. These characteristics are very similar to those of u-FSH. Clinical efficacy and safety are currently demonstrated through several randomized, well controlled studies, comparing r-FSH administered s.c. with u-FSH administered i.m. for stimulating follicular development prior to assisted reproduction treatment and in World Health Organization (WHO) group II anovulation. To date, approximately 1000 patients have been treated with r-FSH. Moreover, r-FSH has recently been used successfully in association with recombinant human LH for inducing ovulation and pregnancy in WHO group I anovulatory patients. At this stage of r-FSH preparation assessment, it is likely that r-FSH will replace all urinary-derived FSH preparations for stimulating ovarian follicular development. For clinicians, current experience with r-FSH indicates that it should be used with the regimes and doses applied to u-FSH.
Loumaye
E
E
Medical Affairs Department, Ares Serono, Geneva, Switzerland.
Campbell
R
R
Salat-Baroux
J
J
D000818:Animals; D000858:Anovulation / Q000188:drug therapy; D016466:CHO Cells; D006224:Cricetinae; D003412:Cricetulus; D004274:DNA, Recombinant; D005260:Female; D043373:Follicle Stimulating Hormone, Human / Q000096:biosynthesis* / Q000493:pharmacokinetics / Q000627:therapeutic use; D006801:Humans; D011247:Pregnancy; D011994:Recombinant Proteins / Q000096:biosynthesis / Q000493:pharmacokinetics / Q000627:therapeutic use; D027724:Reproductive Techniques, Assisted; D013678:Technology, Pharmaceutical
D004274:DNA, Recombinant; D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins