Removal of annexin V–positive sperm cells for intracytoplasmic sperm injection in ovum donation cycles does not improve reproductive outcome: a controlled and randomized trial in unselected males

Objective To determine the effect of removing presumptive apoptotic sperm cells from samples from unselected males by means of magnetic activated cell sorting (MACS) on live-birth delivery rates after intracytoplasmic sperm injection (ICSI) in couples undergoing ovum donation (OD). Design Prospective, randomized, triple-blinded, and controlled study. Setting Private university-affiliated IVF center. Patient(s) A total of 237 infertile couples undergoing ICSI as part of an OD program. Intervention(s) Semen specimens from the control group were prepared by swim-up. Samples from the study group were prepared by swim-up followed by MACS and incubation with annexin V–conjugated microbeads to remove annexin V–positive (AV+) sperm cells. Main Outcome Measure(s) Fertilization rates, morphological features of early embryo development, implantation rates, ongoing pregnancy rates, and live-birth rates. Result(s) Similar results were obtained between groups for all the parameters compared: fertilization rates of 75.3% (95% confidence interval [CI], 71.6–78.9) versus 72.1% (95% CI, 68.6–75.7); percentage of good-quality embryos on day 2 of 53.7% (95% CI, 50.3–57.1) versus 51.8% (95% CI, 48.3–55.3) and on day 3 of 54.2% (95% CI, 50.7–57.6) versus 48.9% (95% CI, 45.3–52.4); implantation rates of 42.2% (95% CI, 33.8–48.1) versus 40.1% (95% CI, 34.8–49.6); positive beta-hCG tests of 63.2% (95% CI, 54.7–71.6) versus 68.6% (95% CI, 60.2–76.9), and live-birth rates of 48.4% (95% CI, 39.6–57.1) versus 56.4% (95% CI, 47.3–65.5) in the MACS versus control group. None of the differences reached statistical significance. Conclusion(s) Applying MACS technology to remove AV+ sperm cells from unselected males does not improve the reproductive outcome of ICSI in OD.