Home semen analysis tests as a screening tool for fertility patients
Research type
Research Study
Full title
Home semen analysis tests as a screening tool for the initial assessment of patients referred to the fertility clinic: Assessing the feasibility of a randomised trial in the UK
IRAS ID
328028
Contact name
Ashleigh C Holt-Kentwell
Contact email
Sponsor organisation
University of Aberdeen
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
Infertility, defined as the inability to conceive after 12 months of regular unprotected intercourse, is estimated to affect 1 in 7 heterosexual couples. Semen analysis, carried out as per the detailed World Health Organisation (WHO) standards in an andrology laboratory, is the primary investigation for the male partner presenting to the fertility clinic and reports on multiple semen parameters. Hospital clinic attendance is required, which could be at a significant distance from the patient’s home, to produce a sample at a given appointment time that is then analysed by the laboratory without delay, as the results are time sensitive. A formal report is produced after several weeks. This process was not sustainable during the Covid pandemic and these methods would be threatened by similar situations in the future.
Despite semen analysis being an essential component of fertility work-up the WHO themselves state that the test does not distinguish between fertile and infertile men. In addition, it involves a significant cost to the national healthcare system. Therefore, a more efficient initial test of male fertility warrants consideration.
Home semen analysis tests are a screening tool that provide a simplified, initial assessment. They are widely available to purchase in the UK, but are not currently issued to patients seen in NHS clinics. They have the potential to reduce time to diagnosis and reduce the cost to the healthcare provider.To investigate the clinical and cost effectiveness of using home semen analysis tests a randomised controlled trial (RCT) is needed comparing them to laboratory semen analysis (standard care). Before a fully-fledged national trial is planned in a UK setting, we would like to undertake a feasibility study to answer, “Is it feasible to conduct a trial comparing home semen analysis tests with current standard practice for the initial assessment of men referred to the fertility clinic?”
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0336
Date of REC Opinion
23 Oct 2023
REC opinion
Further Information Favourable Opinion