Abstract

Background and Aims: The Sperm DNA Fragmentation (SDF) assay has been a promising tool for evaluation of male fertility in assisted reproductive technology (ART). Our primary aim is to assess the impact of SDF levels (<15% and ≥15%) on the laboratory and clinical outcomes; and secondary aim to evaluate those outcomes among 3 ART subgroups namely IVF–ICSI Split, IVF and ICSI cycles. Method: This retrospective cohort study was conducted on 1148 males who presented along with their partners for infertility management at the PIVET Medical Centre between 2013 and 2022 and had their SDF assay performed by Halosperm. They undertook 1600 ART cycles with outcomes divided into 2 groups based on SDF levels <15% and ≥15%. Categorical data were analyzed by Chi-squared or Fisher’s exact test. Results: The overall rates of fertilization, blastocyst development, good–quality blastocyst, clinical pregnancy, miscarriage and livebirth rates were comparable between the <15% and ≥15% SDF groups. Nevertheless, when comparing these outcomes according to female age groups, the clinical and livebirth rates were significantly higher in women <35 years in the SDF <15% (44.1%, p=0.04; 38.6%, p<0.01). Among the 3 ART modalities, the fertilization rates were optimised in both SDF groups by ICSI (75.5%, p<0.0001; 74.1%, p<0.0001), however ICSI also has the lowest blastocyst rate in both SDF groups (p<0.0001 and p<0.001). The IVF-ICSI Split modality generated the highest rate of good-quality blastocysts in both SDF groups <15% (44.9%, p<0.0001) and ≥15% (50.0%, p<0.001). Although the clinical pregnancies were not highest in the IVF modality, it carried the lowest miscarriage rate resulting in the highest live birth rate in SDF <15% group where the women were aged <40 years. Conclusion: The SDF assay is predictive of clinical and livebirth rates for women aged <35 years. IVF is an effective modality among women aged <40 years where the SDF level is <15%.

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