Quality specifications for seminal parameters based on clinicians' opinions.

Area of Science:

• Reproductive Medicine
• Clinical Chemistry
• Andrology

Background:

• Establishing analytical quality specifications is crucial for accurate semen analysis.
• Current specifications often rely on biological variability and technological capabilities.
• Clinicians' perspectives are vital for defining clinically relevant quality targets.

Purpose of the Study:

• To identify analytical quality specifications for seminal parameters based on expert clinician opinions.
• To compare these clinician-derived specifications with those based on biological variability and the current state of the art.

Main Methods:

• Utilized questionnaires sent to laboratories and specialist clinicians in Spain.
• Determined critical difference (CD) for semen analysis parameters.
• Calculated analytical quality specifications based on clinician feedback.

Main Results:

• Clinician-defined critical differences varied depending on the clinical scenario (improvement/worsening) and seminal parameter.
• For concentration and total motility, clinician-based coefficients of variation were often stricter than biological variability.
• For other parameters like motility (a+b, a), morphology, and vitality, clinician opinions suggested higher variability than biological norms but stricter than the state of the art.

Conclusions:

• Analytical quality specifications for semen parameters are significantly influenced by the specific clinical context and the parameter under examination.
• Clinician opinions provide a valuable, context-dependent layer to quality specification setting.