Therapeutic donor insemination: a prospective randomized trial of fresh versus frozen sperm.

OBJECTIVE We evaluated the efficacy of fresh versus frozen sperm in therapeutic donor insemination. STUDY DESIGN Fifty-seven women underwent 72 courses of treatment (a maximum of six therapeutic donor insemination cycles--three fresh and three frozen) totaling 198 cycles. Each woman served as her own control and was prospectively randomized to receive a single, timed insemination of either fresh or frozen sperm. RESULTS Fecundity was 20.6% for fresh sperm cycles and 9.4% for frozen (p less than 0.03, by chi 2 analysis). Fresh cervical cap insemination fecundity was 20.3%; frozen was 7.8% (p less than 0.03, by chi 2 analysis). Fresh intrauterine insemination fecundity was 21.2%; frozen was 15.8% (p = 0.63, by chi 2 analysis). Fresh 3-month life-table pregnancy rates were 48% +/- 10%; frozen rates were 22% +/- 8% (p = 0.05 by Breslow analysis). Survival analysis with fixed covariates showed a positive association with the use of fresh sperm (p = 0.04). CONCLUSION Cycle fecundity was significantly greater with fresh sperm in women undergoing cervical cap insemination or intrauterine insemination and in women undergoing only cervical cap insemination. These results have important implications for contemporary management of patients undergoing therapeutic donor insemination with frozen sperm.