ABSTRACT

The use of exogenous gonadotrophins to induce ovulation is a well established practice for the management of infertility.1 From the late 1950s, these were prepared using urine obtained from menopausal women (human menopausal gonadotrophin, hMG),2 and an international reference standard was established with such preparations.3 However, the early preparations were of low purity and specific activity (8 IU/mg protein), and contained both follicle stimulating hormone (FSH) and luteinizing hormone (LH).4 Although the development of immunopurification techniques during the 1980s5,6 enabled the production of urinary FSH (u-hFSH) preparations from which LH had been removed and with increased specific activity (e.g. Metrodin, Ares-Serono, Geneva, Switzerland, 100-150 IU/mg protein; Metrodin HP, Ares-Serono, Geneva, Switzerland, 9000 IU/mg protein), the increasing demand for assisted reproductive techniques (ART) during the same period required the collection of ever larger volumes of urine. For example, the annual production of Metrodin HP requires 60 million litres of urine to be collected from approximately 300,000 donors.1,4 Although these relatively pure urinary FSH preparations proved significantly more potent than other hMG preparations, they have since been discredited because of their batch to batch inconsistently. Thus, there was a clear need for a safe, reliable and cost-effective source of FSH.