Recombinant human follicle-stimulating hormone: a controversial issue--without controversy

Recent developments in recombinant DNA technology have resulted in a rapidly expanding range of new diagnostic and therapeutic opportunities. This technology paved the way for identification, isolation, cloning and production of specific proteins. Recently, recombinant human gonadotropins became available for clinical use. Pharmacokinetics, receptor availability, pharmacodynamics and safety were extensively studied and the drugs were found to be identical, if not superior, to urinary gonadotropins that have been used in reproductive medicine for the last 40 years. It is currently apparent that the use of recombinant human gonadotropins is expected to provide improved batch-to-batch consistency, steady supply and most importantly, a purified compound with highly specific activity, which accounts for > 99% of the protein content of the preparation, making it possible to administer subcutaneously. The purpose of this report is to describe and evaluate recent developments in the use of recombinant human follicle-stimulating hormone.