Objective: To determine the relationship between sperm chromatin structure assay (SCSA) parameters (DNA fragmentation index [DFI] and high DNA stainability [HDS]), and conventional IVF and IVF/intracytoplasmic sperm injection (ICSI) outcomes. Design: Retrospective review and prospective study. Setting: Private IVF clinic. Patient(s): Two hundred forty-nine couples undergoing first IVF and/or ICSI cycle. Intervention(s): IVF, ICSI, blastocyst culture. Main Outcome Measure(s): DFI, HDS, conventional semen parameters, IVF, ICSI. Results: IVF and ICSI fertilization rates were not statistically different between high- and low-DFI groups. More men with greater than or equal to15% HDS had lower (<25% and <50%) IVF fertilization rates. High DNA stainability was not related to ICSI fertilization rates. High DNA stainability did not affect blastocyst rates or pregnancy outcomes. Men with greater than or equal to30% DFI were at risk for low blastocyst rates (<30%) and no ongoing pregnancies. Men with greater than or equal to30% DFI had more male factors. World Health Organization thresholds were not predictive of ongoing pregnancy. Conclusion(s): The relationship between HDS and poor IVF fertilization rates provides preliminary evidence that ICSI may be indicated in men with greater than or equal to15% HDS. Men with high levels of DNA fragmentation (greater than or equal to30% DFI) were at greater risk for low blastocyst rates and failure to initiate an ongoing pregnancy. The SCSA provides valuable prognostic information to physicians counseling couples before IVF and/or ICSI cycles. (Fertil Steril((R)) 2004;81:1289-95. (C)2004 by American Society for Reproductive Medicine.).
