Recombinant human follicle stimulating hormone for treatment of male idiopathic infertility: a randomized, double-blind, placebo-controlled, clinical trial. Effect of follicle-stimulating hormone on sperm quality and pregnancy rate. Treatment of severe oligospermia with human chorionic gonadotropin/human menopausal gonadotropin: a placebo-controlled, double blind trial. Treatment of male idiopathic infertility with recombinant human follicle-stimulating hormone: a prospective, controlled, randomized clinical study.
To examine the role of recombinant human follicle stimulating hormone (rhFSH) in male idiopathic infertility a randomized, double-blind, placebo-controlled study was performed. Of 211 patients screened, 67 were finally included. After two pre-examinations, patients were randomized and treated for 12 weeks, either with 150 IU rhFSH or with placebo. Examinations (physical examination, scrotal ultrasonography, semen analysis, hormone measurements, and in 31 patients electron microscopy (EM) of spermatozoa were performed 6 and 12 weeks after treatment initiation and 6 and 12 weeks after completion of treatment. Pregnancies were recorded for a further 3 months after the last examination. Of the 67 patients included in the study, 34 treated and 31 placebo patients could be analysed. In the treated group, FSH was elevated compared to baseline values (P < 0.001). At the end of treatment testicular volume in the treated group was increased compared to placebo (P < 0.05) and baseline (P < 0.001). Apart from an increase in sperm motility (P < 0.05) in the placebo group and in sperm DNA condensation (P < 0.001) in the treated group no significant changes were observed in semen parameters. Two spontaneous pregnancies in partners of men in the treated group and none in the placebo group occurred. However, two pregnancies occurred in partners of men in the placebo group induced by intrauterine insemination or intracytoplasmic sperm injection. In conclusion, at the chosen dose and duration, rhFSH did not lead to an improvement of conventional or EM sperm parameters nor to an increase in pregnancy rates. However, the increased testicular volume and sperm DNA condensation give reason for further investigations. To evaluate the possible links between ultrastructural sperm quality and the clinical pregnancy rate in infertile males treated with FSH before intracytoplasmic sperm injection (ICSI).
                Forty-four infertile males with idiopathic oligo-asthenozoospermia were randomly allocated to the treated (n=24) and non-treated (control, n=20) groups. Semen analysis was carried out by light and transmission electron microscopy (TEM) before and 12 weeks after FSH therapy. ICSI was performed in all couples.
                TEM revealed a significant improvement in sperm quality after FSH treatment, particularly in men with their partners achieving clinical pregnancy. The pregnancy rate was 33 % in the treated group and 20 % in the control.
                RESULTS highlight a positive role of FSH therapy in infertile males before ICSI, which was correlated with an increased pregnancy rate in treated couples. We believe that improved sperm ultrastructure after FSH therapy could positively influence the quality and early stage of embryo development, thereby increasing the probability of embryo implantation. In an effort to evaluate the effect of hCG/human menopausal gonadotropin (hMG) treatment on semen parameters in normogonadotropic men suffering from oligospermia, a double blind, placebo-controlled study was conducted. After 2 basal examinations of seminal parameters and reproductive hormones, 39 men were recruited for the trial. Nineteen men, allocated randomly to the active drug group, received im injections of 2500 IU hCG twice a week in combination with 150 IU hMG three times a week for 13 weeks, while 20 men were treated, following the same injection schedule, with NaCl only. After the 13-week treatment period, follow-up examination was performed, followed by 3 additional examinations at 4-week intervals. Of those men receiving hCG-hMG, 2 induced pregnancies in their wives, while no pregnancies were reported in the placebo group. Sperm concentrations, the percentages of motile sperm, and the proportions of normally formed spermatozoa, however, were similar in the 2 groups at all times. It was not possible to predict the outcome of treatment based on results of GnRH and hCG tests performed before the treatment phase. To evaluate the effects of treatment with FSH on seminal parameters and spontaneous pregnancy in male infertility.
                Prospective, controlled, randomized clinical study.
                Infertility center at a university hospital.
                One hundred twelve men affected by idiopathic oligozoospermia.
                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.
                Seminal parameters, testicular cytologic analysis, FSH, LH, T, and inhibin B concentrations.
                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.
                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.
The number of trials and participants is insufficient to draw final conclusions. A large multicenter study with adequate power is needed.