Total concentrations of follicle stimulating hormone (FSH) were evaluated in daily urine samples from conceptive and nonconceptive menstrual cycles by measurement of the FSH beta subunit following treatment of the samples to dissociate the FSH heterodimer. Samples were self-collected by normal subjects during cycles in which daily blood samples also were obtained. Daily blood and urine specimens were collected prospectively from 10 subject in conceptive cycles, which led to normal pregnancies, and from 10 subjects with bilateral tubal ligations to provide control samples form nonconceptive cycles. Mean serum and urinary FSH concentration profiles wer parallel in both groups following ovulation and during he first 9 days of the luteal phase. Mean values for both serum and urinary FSH rose significantly above the postovulatory baseline by 10-12 days following the midcycle luteinizing hormone (LH) peak in nonconceptive cycles, but did not rise at any time following ovulation during conceptive cycles. Following regression analysis of the changing FSH concentration between days 9-14 post-LH surge in conceptive cycles, a slope of </= 0.02 ng FHS/mg creatinine/day was selected as a cutoff point to identify conceptive cycles. There was a high concordance between the day of LH peak in serum and the day of FSH peak in urine. Therefore, in applying the algorithm, the day of FSH peak in urine was used to determine the days for which the FSH slope would be calculated, i.e., days 9-14 post-FSH peak in urine. The sensitivity and specificity of the change in urinary FSH concentrations to detect pregnancy in a different set of 55 cycles were found to 88.9% and 89.3%, respectively. All six cases of early fetal loss in the sample set were correctly identified. These results suggest that urinary FSH can be used as an additional biomarker for the verification of early pregnancy in prospective epidemiological studies in which early fetal loss is a suspected outcome.