Standardization of therapeutic, urinary gonadotrophins: an update on the use and availability of International Standards for Menotrophin

Abstract

The potencies of therapeutic preparations of gonadotrophins of human, urinary origin, which comprise a heterogenous mix of isoforms with follicle-stimulating hormone (FSH) and luteinizing hormone (LH) bioactivities, are standardized by WHO International Standards (IS). We report here, the evaluation, through an international collaborative study, of a candidate preparation, coded 10/286, to replace the 4th IS, 98/704, for human, urinary FSH and LH (Menotrophin) which has been used for many years for the potency assignment of therapeutic preparations using bioassays. The mean FSH and LH bioactivities of 10/286, determined by in vivo bioassays in terms of 98/704, were 183 IU per ampoule (95% confidence limits 165-202) and 177 IU per ampoule (95% confidence limits 159-197), respectively.

Keywords: Collaborative study; FSH; Follicle-stimulating hormone; Human menopausal gonadotrophin; IRP; IS; IU; International Reference Preparation; International Standard; International Unit; LH; Luteinizing hormone; Menotrophin; follicle-stimulating hormone; luteinizing hormone.