Efficacy and safety of recombinant human follicle-stimulating hormone in men with isolated hypogonadotropic hypogonadism.
OBJECTIVE
To assess the efficacy and safety of recombinant human follicle-stimulating hormone (rhFSH; follitropin alpha) in increasing sperm concentration in 26 men with severe isolated hypogonadotropic hypogonadism (IHH).


METHODS
Clinical and endocrine studies using an open design.


METHODS
Six university clinical sites in three European countries.


METHODS
Azoospermatic patients aged 16 to 48 years with IHH.


METHODS
Patients received hCG for up to 6 months before 18 months of treatment with rhFSH. Sperm count, motility, and morphology were assessed every 3 months.


METHODS
Achievement of a sperm concentration of 1.5 x 10(6)/mL.


RESULTS
Spermatogenesis was achieved in 15 of 19 patients who could be evaluated, 12 achieving a sperm concentration of > or =1.5 x 10(6)/mL.


CONCLUSIONS
With hCG, rhFSH is effective in initiating spermatogenesis in patients with IHH, and is well tolerated.
Bouloux
Pierre
P
Centre for Neuro-endocrinology, Royal Free Hospital, London, United Kingdom.
Warne
David W
DW
Loumaye
Ernest
E
D000293:Adolescent; D000328:Adult; D006063:Chorionic Gonadotropin / Q000008:administration & dosage / Q000627:therapeutic use; D004958:Estradiol / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy* / Q000503:physiopathology; D007265:Inhibins / Q000097:blood; D008297:Male; D008875:Middle Aged; D009845:Oligospermia / Q000188:drug therapy / Q000503:physiopathology; D011247:Pregnancy; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013076:Sperm Count; D013081:Sperm Motility / Q000187:drug effects; D013091:Spermatogenesis / Q000187:drug effects / Q000502:physiology; D013739:Testosterone / Q000097:blood
D006063:Chorionic Gonadotropin; D011994:Recombinant Proteins; D013739:Testosterone; D004958:Estradiol; D007265:Inhibins; D005640:Follicle Stimulating Hormone