Dear EMBCOL newsletter subscribers,
Sperm DNA plays an important role in human reproduction. There is fair amount of evidence demonstrating the clinical usefulness of sperm DNA fragmentation (SDF) testing during male fertility evaluation. The unique aspect of SDF testing in providing assessment of genetic contents and quality of the male gamete should be included in the clinical management of infertile couples. Our goal in writing this guideline article was to summarize the rapid advancements in SDF testing and propose specific clinical indications in an evidence-based approach. Subsequently, the literature on SDF testing, including etiologies, risk factors, laboratory assays, implications on reproductive outcomes and appropriate clinical management has expanded dramatically. Nevertheless, the clinical application of SDF testing in male factor evaluation continues to be debated, lacks consensus and is underutilized. We therefore believe there is an urgent need of a high-quality evidence-based review and clinical guideline to consolidate the clinical role of SDF testing in male infertility evaluation. An expert panel of 24 leading andrologists (includes 14 well known, practicing clinicians with expertise in male infertility and ten renowned researchers in male reproduction and infertility) experienced in all aspects of SDF testing have actively collaborated over the past six months to author an evidence based clinical guidelines manuscript.
The hall mark of this unique article is that the authors have: 1) carefully curated all available high quality evidence on the role of SDF in clinical management of couples with male factor infertility, 2) developed a consensus on the clinical use of SDF testing in specific scenarios by our team of renowned experts, 3) conducted a Strengths-Weaknesses-Opportunities-Threats (SWOT) analysis to test the utility of SDF test and lastly 4) conceived and created five original, high quality illustrations to explain the origin, etiologies, risk factors, and the nature of SDF and last, 5) created four comprehensive tables covering data from hundreds of studies in support of a) SDF cut off values for the prediction of pregnancy outcomes using different laboratory assays, b) clinical indications for SDF testing with quality of evidence extracted from about 160 clinical trials, c) therapeutic interventions for SDF with quality of evidence extracted from about 70 clinical trials, and last d) comparison of different SDF tests in terms of principles, advantages and disadvantages.
The clinical guideline article begins with a summary of basic scientific findings on origins, etiologies, risk factors, and the nature of SDF before moving onto the discussion of the available SDF assays. It is followed by clinical indications for the test, supported by various case scenarios. Moreover, recent developments in the clinical management of patients with high SDF are also discussed. Finally, the clinical guidelines are concluded by expert recommendations and SWOT analysis on the clinical utility of SDF in specific male infertility scenarios. This new guideline will help the reproductive professionals gain a better understanding of SDF testing and promote its wider clinical application, which in turn may enhance the reproductive outcome of couples suffering from the debilitating disease of infertility”.
You can download the document here.
Respectfully submitted,
Ashok Agarwal, PhD, HCLD, EMB
Professor of Urology, Case Western School of Medicine and Lerner College of Medicine
Director, Andrology Center and Reproductive Tissue Bank Director, American Center for Reproductive Medicine
Director, Summer Internship in Reproductive Medicine
Director, Assisted Reproductive Technology Training Staff, Department of Urology, Ob-Gyn, Immunology and Anatomic Pathology Cleveland Clinic Foundation 10681 Carnegie Avenue, Desk X11 Cleveland, Ohio 44195
Email: agarwaa@ccf.org Website: https://clevelandclinic.org/reproductiveresearchcenter/