Quasi-randomized pilot clinical trial comparing the use of annexin columns in patients with abnormal sperm FISH undergoing IVF techniques

Several studies have shown that Magnetic Activated Cell Sorting (MACS), also known as annexin columns, are capable of eliminating sperm with chromosomal abnormalities in IVF. So, it is a promising tool for men with abnormal sperm FISH results, since they select better-quality gametes with normal chromosomal content, mitigating the poor reproductive outcomes caused by this alteration. Our study (quasi-randomized clinical trial) is the first to evaluate the efficacy of MACS in patients with abnormal sperm FISH results in terms of IVF laboratory results. In addition, we communicate a descriptive analysis of the cases in which sperm FISH was performed during the study period to investigate the prevalence of abnormal results among the indications for which this technique was requested. The overall prevalence of patients with abnormal sperm FISH results was 8.5%, but it varied. This prevalence was 13.9% when indication for the analysis was male factor, 9.1% when recurrent miscarriages in combination with male factor, and 2.7% when only recurrent miscarriage. The use of MACS in addition to conventional technique for patients with abnormal sperm FISH results undergoing IVF-ICIS reported no differences versus the control group in fertilization rates (66.7% vs. 69%, p = 0.75), abnormal fertilization (8.3% vs. 4.2%, p = 0.49), biopsiable embryos (87.5% vs. 83.7%, p = 0.73) and euploidy (30.8% vs. 30%, p = 0.93). Sperm FISH analysis is a useful test in the diagnosis of infertility for couples with male factor and/or recurrent miscarriage. The use of MACS in patients with abnormal sperm FISH showed no evidence of differences in the laboratory results analysed in the limited cohort studied. ClinicalTrials.gov registration: NCT06524102.