Human Reproduction, Vol 13, 596-603, Copyright © 1998 by Oxford University Press
A Kamischke, HM Behre, M Bergmann, M Simoni, T Schafer and E Nieschlag
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.
ARTICLES
Recombinant human follicle stimulating hormone for treatment of male idiopathic infertility: a randomized, double-blind, placebo-controlled, clinical trial
Institute of Reproductive Medicine of the University, Munster, Germany.
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