The Damage Detection technique is an innovative approach to assessing Single Strand DNA (ssDNA) damage by utilizing DNA repair enzymes to identify DNA adducts and single-strand breaks. Spermatozoa are characterized by high levels of DNA fragmentation, despite their condensed nuclear DNA packaging. Sublethal DNA damage, such as single strand breaks and adducts, can occur and these types of damage can be transferred to future generations. Genetic damage is a significant contributor to infertility severely affecting: fertilization and implantation rates, disrupting embryo development, reduce implantation rate and increase abortion rate. This technology introduces a novel robust sperm analysis technique that is efficient and sensitive for detection of ssDNA breaks and DNA adducts in sperm cells with high sensitivity. The technique was found reliable and reproducible when compared with other widely used assays. Our results show a lack of correlation between ssDNA damage and the standard WHO sperm criteria, indicating that these criteria are insufficient for predicting sperm quality.

UNMET NEED
Infertility health problem affecting ~15% of couples in reproductive age. Male factor is responsible for 40-50% of all infertility cases. Traditional semen analysis methods (volume, count, motility & morphology) do not provide a broad insight into male fertility potential. Recent studies have shown that assessing sperm DNA integrity can be a useful diagnostic tool for male infertility. WHO concludes that sperm genetic tests are “an important addition in the work-up of male infertility.” This is crucial since most ssDNA damage is composed of chemical adducts that do not compromise DNA integrity but can impede replication or transcription and eventually lead to mutations or cell death which in turn can affect fertilization, embryo development, and pregnancy outcome.

OUR SOLUTION
> The suggested damage detection technique is advantageous for the following reasons:
> It is a robust, high-throughput & highly sensitive assay for the detection & quantification of type-specific single-strand DNA (ssDNA) damage and adducts in sperm.
> It is accurate and objective in enabling specific damage site detection due to its’ unique components.
>  Low number of sperm cells are needed to proceed with the assay.
> Many sperm samples (up to 90) can be evaluated simultaneously.
> Low cost. No expensive tools are needed.
>  Can be easily adapted by infertility centres
> It is an excellent alternative to the conventional sperm analysis.

APPLICATIONS
Infertility Centers: infertility clinics, male clinics, ART centers
>  For Infertility workup (routine screening): WHO recommendations.
> Male factor infertility investigation
> Repeated fertilization failure
> Unexplained infertility
> Repeated implantation failure
> Repeated abortions
> Analysis of at-risk populations: Occupational, medical, cancer patients.
Sperm banks for selecting donors.
Pharmaceutical Industry for toxicology testing of drugs

STATUS
The technique was tested side by side and was shown to be at least as good as current gold standards. In addition, the technique managed to identify DNA damage in sperm donor samples which passed the current analysis methods, proving its higher sensitivity.
The project received a highly competitive incentive grant from Israel’s Innovation Authority, aimed at directing and transferring knowledge from academia to industry to support applied research in academia. Recently, all developmental milestones were successfully achieved.