Investigation into male factor infertility for optimisation of testing
Research type
Research Study
Full title
Investigations into male factor infertility for optimisation of testing
IRAS ID
352023
Contact name
Tara Moore
Contact email
Sponsor organisation
Ulster University
Duration of Study in the UK
2 years, 6 months, 25 days
Research summary
One in six couples are affected by infertility with male infertility contributing to around 50% of all cases. Known factors that affect male fertility are sperm count, morphology, motility and sperm DNA fragmentation (SDF) which refers to the presence of breaks or damage in the sperm DNA. SDF can affect fertility and outcomes of a pregnancy. Despite four assays being accepted by the World Health Organisation, explanation for when testing is recommended and clear guidance on diagnostic thresholds is lacking which has limited global uptake.
This study aims to assess SDF analysis in predicting male infertility, pregnancy loss and failed assisted reproductive technologies. SDF will be measured using established and novel methods where multi-nomic biomarkers will be assessed. The study will also assess how lifestyle choices impact upon SDF levels.
This research will be conducted in collaboration with Examen Belfast, which obtains consent from patients to use the remnants of the sperm samples that they have already provided for testing and to be followed up for further information-gathering exercises. Once consent is received the participant will be asked to complete a questionnaire to gain insight into their lifestyle and fertility journey history. Samples will be tested for SDF and biomarkers related to infertility using various methods. Participants will also be asked to complete follow-up questionnaires throughout the study, pertinent to fertility and lifestyle changes. Statistical analysis will assess the predictive power of SDF for failure to conceive (naturally or through ART) and miscarriage. Correlations between multi-omic biomarkers; male infertility; and SDF will also be analysed.The participant's female partner will also be invited to complete questionnaires throughout the study to view how the female's infertility could be contributing to the issue and to ensure that any observed changes in fertility are not related to changes in the female's lifestyle.
REC name
HSC REC B
REC reference
25/NI/0066
Date of REC Opinion
18 Apr 2025
REC opinion
Further Information Favourable Opinion