Sperm DNA fragmentation measured by the Exact® test is a novel biomarker for early pregnancy loss

By The Examen Team

26-10-2020



New study reveals Sperm DNA damage is a key indicator of the likelihood of miscarriage

Belfast, UK, 26th October 2020 / A new study demonstrates that sperm DNA damage, measured by Exact® tests using an alkaline Comet assay, acts as a reliable biomarker for sporadic and recurrent miscarriage in both spontaneous and assisted conception. The study, published in Reproductive Biomedicine Online (RBMO), was co-authored by fertility experts from Examen Ltd, Epsom and St. Helier University Hospitals NHS Trust, Cryos International and The Centre for Reproductive Immunology and Pregnancy (CRP Clinic). Its findings suggest that sperm DNA fragmentation should be analysed following sporadic or recurrent miscarriages, whether conceived spontaneously or by assisted conception, as there is a strong link between DNA damage and miscarriage. This novel finding provides useful guidance for future pathways for miscarriage couples.

The study compared the sperm DNA fragmentation of men whose partners have miscarried with that of men with recently proven fertility. An alkaline Comet assay was used to calculate the average level of sperm DNA damage (average comet score), the proportion of sperm with low DNA damage (low comet score) and the proportion with high DNA damage (high comet score) as measures of sperm DNA quality. The scores were assessed to determine whether they are reliable biomarkers to diagnose miscarriage and to develop clinical thresholds for comparison. Male partners of women who had miscarried were found to have higher sperm DNA damage than fertile men and all three parameters were highly predictive of both sporadic and recurrent miscarriage.

Sperm DNA damage is a leading cause of male infertility and is often under-investigated prior to fertility treatment. The Comet assay has previously been shown to improve the diagnosis of unexplained infertility and the prediction of the outcome of both Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilisation (IVF) fertility treatments. Exact sperm DNA tests are powered by Examen’s alkaline Comet assay to accurately measure sperm DNA damage. This new study demonstrates that Exact tests are also a powerful tool for understanding early pregnancy loss and diagnosing the causes of sporadic and recurrent miscarriage.

Professor Sheena Lewis, CEO of Examen, commented, “The results of this study reinforce the importance of fully investigating sperm DNA damage routinely when any couple experiences a miscarriage. Male links with miscarriage should receive the same attention as female causes. These results show that sperm DNA damage is a key factor in miscarriage. Utilising Comet technology, Exact tests provide important diagnosis parameters for unexplained infertility, indicate the likelihood of success of IVF or ICSI, and now Exact tests provide an important measure to diagnose miscarriage in all scenarios. Exact tests are the most accurate sperm DNA tests currently available and provide valuable information that could help men become dads.”

Mr Hassan Shehata, Miscarriage Expert and Director of the CRP Clinic, and Mr Stephen Gordon, Lead Male Fertility Specialist at the CRP Clinic, commented, “At the Centre for Reproductive Immunology and Pregnancy we are dedicated in diagnosing and treating miscarriages and providing couples with the best chance of having a successful pregnancy outcome. We believe that when a couple are trying for a child it is important to consider the male partner’s contribution. The results of DNA damage testing can give men and couples reassurance if normal, but if elevated can help focus investigations for potential causes and even offer treatments to improve the sperm. This is one of the first studies of its kind to find a strong link between miscarriage and sperm DNA damage. All couples are entirely unique in terms of their clinical problems and we are grateful to all of our patients who helped aid in this study.”

ENDS

Notes to Editors:

About Examen

Examen is a world leader in male fertility testing with a heritage of over 25 years in male reproductive health and fertility treatment research. Examen specialises in measuring sperm DNA fragmentation (known as sperm DNA damage) to help predict the likelihood of conception, miscarriage and the success of fertility treatment.

Sperm DNA damage is one of the most important factors causing male infertility. Examen has developed the Exact® range of sperm DNA diagnostics tests that empower men to take control of their own fertility.

The Exact tests are powered by Examen’s proprietary COMET technology, previously known as SpermComet®, the most comprehensive sperm DNA analysis currently available and able to deliver an accurate assessment of sperm DNA damage for fertility diagnosis and information that can predict the outcome of IVF and ICSI fertility treatment. The Exact range are the go-to tests for sperm DNA damage in 80% of the UK’s leading fertility clinics.

The founder of Examen is internationally acclaimed academic in male fertility; Professor Sheena Lewis.

For further information, please contact:

Examen
Professor Sheena E. M. Lewis BSc PhD CBiol FRSB, CEO
T: +44 (0)28 9023 8915
E: contact@examenlab.com
W: www.examenlab.com

Sciad Communications
Juliette Craggs / Maria Patey
T: +44 (0)20 3405 7892
E: examen@sciad.com

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