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.
Result(s): IVF and ICSI fertilization rates were not statistically different between high- and low-DFI groups. More men with > or =15% 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 > or =30% DFI were at risk for low blastocyst rates (<30%) and no ongoing pregnancies. Men with > or =30% 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 > or =15% HDS. Men with high levels of DNA fragmentation (> or =30% 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.