The present paper reports the results of a pragmatic prospective trial in a group of 38 random infertile couples in whom a battery of semen assays were performed before in vitro fertilisation (IVF). Sixteen couples (42.1%) attained ongoing pregnancy. Using logistic regression analysis only the result of the Oxisperm® (P = 0.047) and the HaloSperm G2® for DNA fragmentation (P < 0.0001) were significantly associated with the occurrence of pregnancy, whereas neither the conventional semen characteristics, nor the outcome of multiple other tests were significantly related (P > 0.05). Based on the logistic regression analysis the following formula could be derived: Logit(p) = 6.15-0.407 × (% halotest), whereby (p) is the probability of pregnancy, and % halotest is the proportion of spermatozoa showing DNA fragmentation in the HaloSperm G2® test. Receiver operating characteristic curve analysis revealed an area under the curve (AUC) of 0.83. In 16 out of 38 couples the IVF outcome, either positive or negative, could unequivocally be predicted, while in the remaining cases the probability of pregnancy was significantly related to the result of the formula. These findings confirm the hypothesis that sperm DNA-fragmentation largely determines the success of IVF.
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