During spermiogenesis, histone-to-protamine exchange causes chromatin conde
nsation. Spermatozoa from infertile men are known to exhibit an increased p
rotamine-1 (PRM1) to protamine-2 (PRM2) protein ratio. Since patients under
going testicular sperm extraction (TESE) followed by intracytoplasmic sperm
injection (ICSI) reveal low fertilization rates, whether the outcome of IC
SI could be related to the percentage of round spermatids expressing PRM1-m
RNA and PRM2-mRNA was investigated. Applying in-situ hybridization, 55 test
icular biopsies from men undergoing TESE/ICSI were investigated. The percen
tage of PRM1-mRNA and PRM2-mRNA positive spermatids was significantly (P <
0.0001) decreased in men with at least qualitatively normal spermatogenesis
(PRM1-mRNA: 58.4 +/- 13.8%; PRM2-mRNA: 56.4 +/- 11.3%) and impaired sperma
togenesis (PRM1-mRNA: 32.6 +/- 10.8%; PRM2-mRNA: 31.7 +/- 11.1%) compared w
ith men with obstructive azoospermia and quantitatively normal spermatogene
sis (PRM1-mRNA: 79.9 +/- 4.6%; PRM2-mRNA: 78.1 +/- 5.7%). A positive correl
ation (r(PRM1) = 0.733; r(PRM2) = 0.784; P < 0.001) was demonstrated betwee
n the score and the percentage of PRM1-mRNA and PRM2-mRNA positive spermati
ds, While successful fertilization was neither related to the score, nor to
the percentage of PRM1-mRNA and PRM2-mRNA positive spermatids, a significa
nt (P < 0.05) relationship was demonstrated between successful fertilizatio
n and the PRM1-mRNA to PRM2-mRNA ratio. Therefore, the PRM1-mRNA to PRM2-mR
NA ratio in round spermatids may serve as a possible predictive factor for
the outcome of ICSI.