Objective: To determine the clinical significance of albumin determina
tion in ejaculates by means of an easy office test to screen semen sam
ples for subclinical infection-inflammation. Patients: One hundred fif
ty-nine randomly chosen males of couples with longstanding infertility
(median duration of infertility 4 years (range 1 to 19 years) without
clinical signs or symptoms of genital tract infection. Setting: Outpa
tient Infertility Clinic of the University of Heidelberg, Germany. Mai
n Outcome Measures: Screening of ejaculates for subclinical infection-
inflammation by means of a ready-to-use kit for semiquantitative detec
tion of albumin in addition to determination of leukocytes rates by me
ans of monoclonal antibodies for differentiation of round cells and me
asurement of granulocyte elastase concentration in semen samples. Eval
uation of sperm quality by means of standard sperm analysis including
determination of local antisperm antibodies with the mixed antiglobuli
n reaction, evaluation of sperm functional capacity in vitro with the
standardized sperm-cervical mucus (CM) penetration test, and semen cul
tures. All tests were performed from aliquots of the same ejaculates.R
esults: Screening of semen samples for elevated albumin with the modif
ied paper strips proved to be very easy, quick, and suitable for routi
ne use. Positive results were not related markedly to medical history
and outcome of clinical examination as well as to standard parameters
of sperm analysis and were not influenced by local antisperm antibodie
s of the immunoglobulin (Ig)G and/or IgA class and microbial colonizat
ion. However, albumin-positive semen samples were significantly less f
requent in case of very good outcome of the sperm-CM penetration test.
A significant relationship was found with high rates of leukocytes of
the round cells in semen samples (total range 0% to 96%) and the conc
entration of granulocyte elastase (total range 1 to 880 mu g/L). Concl
usions: The results of this prospective study suggest that the determi
nation of albumin in semen samples with ready-to-use test kits might b
e a valuable additional marker for subclinical infection-inflammation
of the male genital tract and therefore suitable for screening during
infertility investigation.