Semen Clinical Studies

Case Study

When Animal model studies suggest that there may be adverse testicular effects due to a study drug, spermatogenesis needs to be evaluated to see if the observed effects are reflected in human participants
Many drugs distribute into seminal fluid and may have direct effects on sperm function, physiology or sperm motility. For drugs that distribute into seminal fluid, clinical studies can be conducted to examine the semen exposure to the study drug and the potential effects on semen parameters
The client required study to be conducted to remove regulatory hold

Conducted reproductive safety evaluations including semen and sperm parameters: sperm concentration, sperm motility (% active), sperm morphology (% normal), sperm viability, viscosity, semen volume, sperm count (semen source, post ejaculatory urine source and total) and total motile sperm count/ejaculate on over 1200 samples
Provided triplicate baseline comprehensive semen analysis (48 hours apart) on 165 participants in less than 1 month
Enrolled large panels and performed semen analysis on 50+ participants in a day
Collaborated with a state of the art Andrology lab for onsite quantitative semen analysis
Morphology interpretations conducted by a single reader
Managed retention of semen samples for PK analysis- utilizing Celerion’s barcoding system for sample tracking
Semen analysis results all captured in our ClinQuick® integrated laboratory results system for easy Principal Investigator (PI) review and simple data extraction
Rapid recruitment of 300 participants in 2 days for long term (spermatogenesis effects) semen studies
Multi site approach to facilitate ethnicity stratification as per client’s request
Facilitated semen analysis data review by an external Advisory Board. The Advisory Board included experts in toxicology, reproductive medicine, and a statistician

Celerion’s specialized semen study capability allowed us to deliver services that enabled the client to transition to the next stage in the product development and deliver key safety information to the regulatory agency
To assist the client in making informed go/no-go decisions on their compound in development as early and quickly as possible