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Hum. Reprod. Advance Access published online on November 2, 2005
Human Reproduction, doi:10.1093/humrep/dei330
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© The Author 2005. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org
Received July 25, 2005
Revised August 28, 2005
Accepted August 30, 2005

Article

Development of a novel home sperm test

L. Björndahl 1, J. Kirkman-Brown 1, G. Hart 2, S. Rattle 3, and C.L.R. Barratt 1*

1 Assisted Conception Unit, Birmingham Women’s Hospital and Reproductive Biology and Genetics Group, Division of Reproductive and Child Health, University of Birmingham, Birmingham, UK
2 DPPM Consulting Ltd, York , UK
3 Genosis Ltd, Kingston, UK

* To whom correspondence should be addressed.
C.L.R. Barratt, E-mail: C.L.Barratt{at}bham.ac.uk


  Abstract

BACKGROUND: The majority of men find the production of a semen sample an embarrassing and stressful experience. Consequently, the availability of an over-the-counter home sperm test, which would reliably and accurately allow the patient to obtain an assessment of fertility potential at their convenience, would be a major benefit. Our objective was to develop and evaluate a home sperm test that provides a visual estimate of the concentration of progressively motile sperm in a semen sample. METHODS: Three particular challenges are described (i) developing a visualization system; (ii) optimization of the detection limit; and (iii) controlling variation due to changes in ambient temperature. The accuracy of the device was tested against two reference methods: computer-assisted sperm analysis (CASA) and a hyaluronate migration test (HMT). RESULTS: In 129 semen samples, where both reference methods agreed (positive or negative), the accuracy of the device was 95%. The observed likelihood ratio of 8.8 indicated that a sample showing a red line in the device was over eight times more likely to have a positive (normal) result in CASA and HMT than a sample without a red line. CONCLUSIONS: The final device provides a visual estimate of the concentration of progressively motile sperm in a semen sample using a test that is completed within approximately 1 h of production of the sample and can be used by the man in the comfort of his own home.

Keywords: cervical mucus/home sperm device/hyaluronic acid/sperm function test/sperm penetration test.
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