According to CDC’s 2016 Fertility Clinic Success Rates Report, there were 263,577 ART (assisted reproduction technology) cycles performed at 463 reporting clinics in the U.S during 2016, resulting in 65,996 live births, which is 1 out of 4 cycles (source: https://www.cdc.gov/art/artdata/index.html). Recent data consistently demonstrate a significant increase in miscarriage in patients with high DNA damage (i.e. fragmentation) compared with those with low DNA damage (for example see: https://academic.oup.com/humrep/article/27/10/2908/749072).
In our work, we collected over 1000 OPD (optical phase delay) maps of donated human sperm cells using the QART interferometric phase microscope (IPM). We then characterized cellular levels of fragmented DNA of these very same cells, using acridine orange (AO) assay and fluorescence microscopy. AO is a dye that emits green fluorescence when bound to double-stranded DNA, and red fluorescence when bound to single-stranded nucleic acids. Five (5) different fragmentation groups are then discriminated based on the AO emitted color.
"This is the first publication - we're aware of - supporting the notion that quantitative optical phase delay information, obtained from label-free human sperm cells, can serve to assess the level of DNA fragmentation in individual sperm cells. This was done in accordance with the Acridine Orange assay - on a cell-by-cell basis" said Prof. Natan. T. Shaked, Founder and Chief Scientist of QART Medical.
QART Medical's product line is focused at operator-friendly, resource-friendly and clinical-lab-adapted compact interferometric microscopes. These products will enable objective characterization and sorting of sperm cells for ICSI procedures, and will allow fertility clinicians to have DNA fragmentation criteria as an add-on to the well established WHO2010 morphological criteria.
"Having a user friendly instrument in the clinic that would enable us to preferentially select non-fragmented sperm cells, without damaging them and then use them for ICSI – would be a long awaited clinical breakthrough. Personally, I believe this could dramatically improve contemporary results, obtainable in ICSI." said Dr Eliezer Girsh, a clinical embryologist and andrologist; the sperm lab and bank manager in Barzilay Medical Center and a member of QART Medical Scientific and Clinical advisory committee.