Efficacy and safety of recombinant human follicle stimulating hormone (Gonal-F) with urinary human chorionic gonadotrophin for induction of spermatogenesis and fertility in gonadotrophin-deficient men

In order to evaluate the efficacy and safety of recombinant human follicle stimulating hormone (r-hFSH) in combination with urinary human chorionic go nadotrophin (HCG) to induce spermatogenesis and fertility in gonadotrophin- deficient men, we conducted a prospective, open, noncomparative multicentre study in two Australian academic medical centres, Ten men with gonadotroph in deficiency requiring induction of spermatogenesis and fertility were tre ated with HCG for 3-6 months followed by the s.c. self-administration of in jections of r-hFSH in combination with HCG for 18 months, Among the eight m en who commenced r-hFSH treatment, seven demonstrated sperm output at a med ian of 6 months and five achieved the target sperm output of 1.5 x 10(6) pe r mi at a median of 9 months of FSH treatment. Mean testicular volume incre ased by 4.2 ml during FSH treatment, Three men produced pregnancies in thei r partners, two of which resulted in the birth of healthy babies and a thir d patient's partner had a miscarriage. We conclude that r-hFSH is well tole rated and effective in inducing testis growth, spermatogenesis and fertilit y in gonadotrophin-deficient men. The efficacy of r-hFSH seems comparable w ith urinary FSH at restoring normal fertility in gonadotrophin-deficient me n.