Power considerations in studies of reproductive effects of vinyl chloride and some structural analogs.

We review the evidence examining the relation of reproductive function and exposure to vinyl chloride and selected structural analogs. Investigation of these compounds for possible reproductive effects has focused on paternal exposure, a much less well studied route than maternal exposure. Drawing on animal models, we discuss what is known about the possible reproductive consequences of exposure to the father as well as to the mother. In evaluating the studies of reproductive outcome in relation to vinyl chloride or analogs, we consider what biologic model may have been tested and whether there was statistical power to detect moderate increases in risk. Parameters influencing statistical power are reviewed, and recommended sample sizes are set out which would insure sufficient power, in future studies, to detect adverse effects.