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.