Treatment of male idiopathic infertility with recombinant human follicle-stimulating hormone: a prospective, controlled, randomized clinical study.
OBJECTIVE
To evaluate the effects of treatment with FSH on seminal parameters and spontaneous pregnancy in male infertility.


METHODS
Prospective, controlled, randomized clinical study.


METHODS
Infertility center at a university hospital.


METHODS
One hundred twelve men affected by idiopathic oligozoospermia.


METHODS
Patients were randomized into two groups: 62 subjects were treated with 100 IU of recombinant human FSH on alternate days for 3 months, and 50 patients did not receive any treatment. Semen analysis was performed in all subjects at the end of this period of treatment and after the following 3 months. Subjects who had not reached spontaneous pregnancy underwent assisted reproductive techniques.


METHODS
Seminal parameters, testicular cytologic analysis, FSH, LH, T, and inhibin B concentrations.


RESULTS
The treatment group considered as a whole did not show modifications in sperm parameters. However, a subgroup of these (30, 48.4%) had a significant increase of sperm count (responder group). In the period including 3 months after the withdrawal of FSH therapy, we observed a significantly higher spontaneous pregnancy rate in the responder group (5 of 30 [16.7%]) with respect to nonresponder and nontreated groups (1 of 32 [3.1%] and 2 of 50 [4.0%], respectively). Furthermore, the improvement of seminal parameters in the responder group allowed these patients to undergo less frequent IVF-ET/intracytoplasmic sperm injection.


CONCLUSIONS
Results from this controlled, randomized clinical trial show that FSH therapy does not improve sperm concentration or pregnancy rate when infertile male patients are chosen solely by the clinical criteria of idiopathic oligospermia and normal FSH concentration. Subgroup analysis, however, does indicate that patients without maturation arrest in addition to the clinical scenario do benefit from medical therapy.
Foresta
Carlo
C
Centre for Male Gamete Cryopreservation, Department of Histology, Microbiology, and Medical Biotechnologies, University of Padova, Padova, Italy. carlo.foresta@unipd.it
Bettella
Andrea
A
Garolla
Andrea
A
Ambrosini
Guido
G
Ferlin
Alberto
A
D000328:Adult; D005260:Female; D043373:Follicle Stimulating Hormone, Human / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007248:Infertility, Male / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D008297:Male; D011247:Pregnancy; D018873:Pregnancy Rate; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D013076:Sperm Count / Q000706:statistics & numerical data
D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins