Abstract
Study question
Does the sperm DNA fragmentation (SDF) level impact the clinical outcome of couples undergoing intracytoplasmic sperm injection (ICSI)?
Summary answer
No significant effect was observed for SDF on the reproductive outcome of couples undergoing ICSI.
What is known already
Sperm DNA Fragmentation (SDF) has emerged as an important biomarker in the assessment of male fertility potential. It is currently being used as one of the advanced sperm function tests along with other conventional methods in male fertility evaluation. The impact of SDF on the reproductive outcomes of ICSI remains to be controversial. Evidence extracted from three meta-analyses have indicated that higher SDF is not associated with a negative impact on ICSI outcomes. On the contrary, another meta-analysis revealed that SDF can have a significant impact on the pregnancy rate of ICSI with an OR of 1.31.
Study design, size, duration
This is a retrospective cohort study carried out in the assisted conception unit of a tertiary medical center. The study duration was over a 5-year period from August 1st, 2014 to August 1st, 2019. The charts of 1922 patients who underwent ICSI were screened for inclusion in the study. Inclusion criteria were patients who underwent ICSI using ejaculate spermatozoa and had a recorded SDF test done within a week before ICSI (n = 390).
Participants/materials, setting, methods
Sperm chromatin dispersion was used to evaluate SDF utilizing the Halosperm G2 test kit (Halotech, Madrid, Spain). All patients performed the ICSI trial using ejaculated spermatozoa. Patients were divided according to the SDF level into 3 groups; SDF <20% (n = 148), SDF 20–30% (n = 133), and SDF >30% (n = 109). Female partner fertility status was recorded and couples were grouped into 2 groups based on age and AMH levels; (1) favorable female and (2) unfavorable female status.
Main results and the role of chance
Overall, clinical pregnancy occurred in 45% of cases, live birth rate was 33.60%, and 1.30% of patients had miscarriage. A significant negative correlation between SDF and sperm count (r–0.232), motility (r–0.469), progressive motility (r–0.312) and normal morphology (r–0.297) was detected (p < 0.001 for all). Fertilization rate, clinical pregnancy and live birth rate were greater in patients with lower SDF than those with higher SDF in both favorable and unfavorable groups, however the difference was not statistically significant (Table 1).
Limitations, reasons for caution
The main limitation of our study was the retrospective nature of the study where some data may be missing or incomplete. The data was also retrieved from one ART center, therefore our data lacked diversity within methodologies for IVF and SDF testing.
Wider implications of the findings: SDF was found to be significantly correlated with conventional semen parameters highlighting its significance as a robust diagnostic test during male fertility evaluation. In this study, while patients with higher SDF values had worse reproductive outcomes with ICSI, the results did not reach statistical significance.
Trial registration number
NA
RAISED SPERM DNA FRAGMENTATION –RANDOMISED CONTROLLED TRIAL OF MACS VS TESA TO OPTIMISE REPRODUCTIVE OUTCOMES
