PUREGON(R) (ORG-32489) - RECOMBINANT HUMAN FOLLICLE-STIMULATING-HORMONE

Follicle-stimulating hormone (FSH) is a complex glycoprotein essential for ovarian follicular development. It is used therapeutically in the treatment of human infertility, especially in anovulatory conditions and as hormonal pretreatment in assisted reproduction technologies suc h as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Until recently, FSH could only be obtained from human urinary sources such as human menopausal gonadotropin (hMG), containing equal amounts of FSH FSH in which the LH content has been largely removed. T he protein contents of most of these preparations contain more than 95 % urinary contaminations. Furthermore, the use of urine implies limite d sources, decreased flexibility and risks for batch-to-batch inconsis tencies. availability of FSH manufactured recombinant DNA technology i s a great improvement. This review summarizes the characteristics of P uregon (Org 32489), a recombinant human FSH preparation, as establishe d in an extensive research and development programme.