O-015 Enabling laboratory-quality male fertility analysis with 72-hour post ejaculation sample viability
Authors: Rustamov O , Ramachandran A , Ebinger E 
Published: July 2024

Study question

Can SPX72-treated semen samples sustain diagnostic viability and integrity for up to 72 hours, enabling comparable analysis of mail-in samples to fresh samples?

Summary answer

SPX72 preserves sperm viability, motility, and integrity up to 72 hours post-collection, equalling the diagnostic precision of fresh samples and enhancing at-home testing capabilities.

What is known already

Challenges with laboratory-based fertility assessments stem from logistical burdens and the necessity for timely sample delivery, often deterring male patient participation. Semen samples typically need to be assessed within 60 minutes of collection to ensure accuracy. Pre-existing solutions have failed to sufficiently prolong sample viability while matching the diagnostic accuracy of immediate laboratory analyses, an issue Sapyen's SPX72 medium addresses effectively.

Study design, size, duration

An exhaustive controlled study with over 100 semen samples compared SPX72-treated samples at 72 hours against fresh controls. The study incorporated actual postal logistics to emulate mail-in scenarios.

Participants/materials, setting, methods

A predetermined quantity of SPX72 per millilitre was added to the collected semen samples, with key indicators, including progressive and total motility, morphology, and DNA fragmentation, measured at intervals of 0, 24, 48, and 72 hours, contrasted with untreated, fresh samples.

Main results and the role of chance

SPX72 application preserved notable semen motility, evidenced by a mean progressive motility of 37.12% after 72 hours, a slight decrease from the initial 41.14%. This minor 4.02% reduction underscores SPX72's proficiency in maintaining diagnostic-grade motility over an extended duration.

In terms of DNA integrity, SPX72 maintained DNA fragmentation at 14.78%, juxtaposed with 12.44% in control samples, a statistically insignificant variance (p-value of 1.15037E-08). This consistency in DNA fragmentation levels is pivotal for the accuracy of fertility diagnostic metrics.

Additionally, SPX72 demonstrated its efficacy in stabilising the pH level of semen samples throughout the 72-hour period, ensuring an optimal environment for sperm preservation. This maintenance of pH is crucial as deviations can significantly affect sperm functionality and overall sample integrity.

These results substantiate SPX72's capacity to preserve diagnostic sperm quality for up to three days, potentially redefining the logistics of male fertility testing by enabling accurate, laboratory-level assessment through a mail-in format.

Limitations, reasons for caution

Despite the controlled study and real-world postal validation, ongoing surveillance of sample stability in diverse global postal environments will be crucial to ensure consistent results across all geographies.

Wider implications of the findings

The data indicate that SPX72 sets a new standard for at-home fertility testing, matching clinical quality without the immediacy constraint. For the first time, home-based sperm diagnostics do not compromise clinical quality, revolutionising how male fertility is approached and managed.

Trial registration number

not applicable