Home Semen Analysis Tests As a Screening Tool for Fertility Patients

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, the investigators 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?"

Conditions

• Male Infertility

Interventions

DEVICE

ExSeed®

In work package 3, participants will use the provided ExSeed® device and associated app downloaded onto their smartphone to analyse a semen sample provided at home. The app gives a result of "normal" or "below normal," as well as an exact value for sperm concentration, progressive motility, and total motile sperm count. The patient will send their semen analysis results from the smartphone to the research team via secure email.

OTHER

Survey

Surveys will be completed on a hard copy or electronically.

Sponsors & Collaborators

• University of Aberdeen

  lead OTHER

Principal Investigators

• Ashleigh C Holt-Kentwell, MBChB · University of Aberdeen

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-08

Primary Completion

2024-02-01

Completion

2024-10-29

Countries

• United Kingdom

Study Locations