Pregnancy Outcomes of Intrauterine Insemination Using Microfluidics ZyMot Device for Patients With High Sperm DNA Fragmentation: An Exploratory Retrospective Study

BACKGROUND: High sperm DNA fragmentation affects male fertility and negatively correlates with sperm survival and pregnancy rates. The use of microfluidic devices allows more rigorous sperm selection, avoiding the centrifugation which is detrimental to DNA integrity. OBJECTIVES: To determine whether the microfluidic ZyMot sperm selection method increases the intrauterine insemination (IUI) pregnancy rate in case of high sperm DNA fragmentation. MATERIALS/METHODS: Retrospective cohort exploratory study including 132 patients with high sperm DNA fragmentation in the time period between December 2022 and December 2024. The microfluidic ZyMot device and density gradient were used to prepare sperm for insemination in 50 and 82 patients, respectively. The study included patients undergoing IUI cycles with fresh sperm samples with high DNA fragmentation, equal or more than 20%, tested within 6 months of the insemination. RESULTS: The IUI pregnancy rates (PR) with the ZyMot method were 8% and for density gradient 9.8%, with no significant difference, p = 1.00. The total motile sperm count (TSM) was significantly higher in the gradient group (35.0 vs. 12.3, p-value < 0.001). For all patients combined with sperm DNA fragmentation index (DFI) between 20% and 30%, the PR was 12.3% and with DFI more than 30% the PR was 3.9%. DISCUSSION: This exploratory research shows that the use of the microfluidic ZyMot device for sperm preparation in IUI for patients with high DNA fragmentation was not associated with a significant increase in pregnancy rate; pregnancy outcomes are comparable between two preparation methods: ZyMot and density gradient. CONCLUSION: While the microfluidic ZyMot method allows more refined sperm selection with lower DFI, its pregnancy outcomes are similar to those of density gradient wash in IUI cycles. Both methods can be used for sperm preparation. The observed difference in pregnancy rates between patients with a DFI of 20%-30% and those with a DFI >30% may indicate a possible trend toward lower IUI success at higher DFI levels, although further studies are needed to confirm this association. LIMITATIONS, REASONS FOR CAUTION: The retrospective study has a high risk of type II error due to small number of participants. Given the exploratory nature, repeated cycles from the same patient may have been included and statistical comparisons should therefore be interpreted with caution.