Current male infertility testing is incomplete, as conventional semen analysis does not assess sperm function. Despite male infertility contributing to around half of all infertility cases, testing often relies solely on conventional semen analysis. This is problematic, as research indicates that 20% to 30% of men with normal semen analysis results are still infertile.
The Link Between Phosphatidylserine (PS) and Fertilization
Our groundbreaking research published in Nature Communications revealed that the presence of phosphatidylserine (PS) on the outer surface of sperm cells is crucial for fertilization. This discovery highlights a significant gap in current fertility testing, as routine assessments have not previously measured PS presence on sperm.
PS Detect is a flow cytometry-based diagnostic test that detects the percentage of sperm that express PS—generating a unique measurement called the PS Score. This innovative metric goes beyond standard sperm count, motility, and morphology to quantify sperm competence.
The key findings from our study, published in the November 2024 issue of the scientific journal JU Open Plus, are as follows. Note: The majority of patients with a varicocele in the study had been trying to conceive for 12+ months.
PS Score correlates with male fertility status. PS Scores were significantly higher in pregnancy-proven donors compared to patients with a varicocele.
PS Scores improved to levels comparable to pregnancy-proven donors in patients who underwent a varicocele repair. This result suggests that the PS Score is effective in identifying patients who would benefit from this procedure. Additionally, 2 out of 7 patients who were trying to conceive achieved pregnancy naturally following the varicocele repair.
Up to 40% of males with infertility have a varicocele, which is an enlargement of the veins of the scrotum. A varicocele repair is a minor surgical procedure to address the condition. Prior to PS Detect, no diagnostic test existed to predict if a patient’s fertility would improve following a varicocele repair.
In our 2024 study, we analyzed 80 patients and found that over 40% had a below-normal PS Score despite normal semen analysis results. This indicates that standard semen analysis would have misdiagnosed these patients as fertile.
The study has now expanded to include over 130 patients, with consistent findings. Following varicocele repair, 25% of the patients who were trying to conceive achieved a natural pregnancy (source: data on file).
PS Detect is changing the way infertility is diagnosed and treated by evaluating sperm competency to provide a more comprehensive picture of male fertility.
Measuring Male Fertility through Sperm Competence
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