Subcutaneous self-administration of highly purified follicle stimulating hormone and human chorionic gonadotrophin for the treatment of male hypogonadotrophic hypogonadism. Spanish Collaborative Group on Male Hypogonadotropic Hypogonadism

The efficacy and safety of highly purified follicle stimulating hormone(FSH) associated with human chorionic gonadotrophin (HCG) was studied in 60men with hypogonadotrophic hypogonadism. Of these men, 16 suffered fromKallmann's syndrome, 19 from idiopathic hypogonadotrophic hypogonadism and25 from hypopituitarism. Basal testosterone concentrations were found to befar below the normal range. At baseline, 26 patients were able to ejaculateand all of them showed azoospermia, while the remaining patients wereaspermic. All patients self-administered s.c. injections of FSH (150 IU xthree/week) and HCG (2500 IU x two/week) for at least 6 months andunderwent periodic assessments of testicular function. Testosteroneconcentrations increased rapidly during treatment and all but one patientreached normal values. Testicular volume showed a sustained increasereaching almost 3-fold its baseline value. At the end of treatment, 48patients (80.0%) had achieved a positive sperm count. The maximum spermconcentration during treatment was 24.5 +/- 8.1 x 10(6)/ml (mean +/- SEM).The median time to induce spermatogenesis was 5 months. Eleven patientsreported adverse events, generally not related to treatment. Three patientsexperienced gynaecomastia. No local reactions at injection site wereobserved. In conclusion, the s.c. self- administration of highly purifiedFSH + HCG was well tolerated and effective in stimulating spermatogenesisand steroidogenesis in these patients.