Sperm DNA testing, Fertility treatment and Miscarriage
Research type
Research Study
Full title
Investigation of the role of sperm quality in fertility diagnosis, fertility treatment and miscarriage
IRAS ID
263828
Contact name
ANDREW DRAKELEY
Contact email
Sponsor organisation
Liverpool Women's NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Male infertility has long been neglected with the woman being the focus of diagnosis and treatment. With infertility increasing 8-9% per year across Europe and success rates remaining modest with only 25% of couples having a baby following treatment, better diagnostic tests and treatments are urgently needed. Thirty percent of these couples are given a diagnosis of idiopathic or ‘unexplained’ infertility. Without a known cause, it is difficult to guide couples to their best treatment either in vitro fertilization; IVF or intracytoplasmic sperm injection; ICSI. This is partially because the routine diagnostic test for the man is a semen analysis; a insensitive, non-specific test that hasn’t changed much since 1940s. Sperm DNA damage is a more useful biomarker for male infertility diagnosis and prediction of assisted reproductive treatment (ART) outcomes. We have reported associations with reduced fertilization rates, lower embryo quality and pregnancy rates after IVF and most recently ICSI. Higher rates of miscarriage have also been observed with DNA-damaged sperm. DNA is made up of a helix of two strands of DNA. Damage can occur in one strand (single strand breaks; SSB) or both strands together (double strand breaks; DSB). We developed the initial SpermComet test that measures total strand break damage: SSB plus DSB. In this study, our aims are to refine our tests to measure DSBs separately as they may be more destructive thus providing a more sensitive and specific assay and to test them over a large scale in several major fertility centres. Secondly, we wish to determine their clinical usefulness in ICSI with surgically retrieved sperm taken from the male reproductive tract. Thirdly, we wish to ascertain the role of sperm DNA damage in miscarriage in couples who have become pregnant naturally and also after fertility treatment. Finally, we wish to develop a faster, cheaper, more male compliant way of transporting semen samples from clinic or home to lab for SpermComet testing.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0345
Date of REC Opinion
20 Nov 2019
REC opinion
Unfavourable Opinion