SDF Inspection Method Evaluation Study

JRCT ID: jRCT1040230049

Registered date:24/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Male infertility patients
• Date of first enrollment: 24/06/2023
• Target sample size: 60
• Study type: Observational

Outcome(s)

• Primary Outcome: The SDF rate will be measured for each sample using the SCSA and TUNEL methods to compare and evaluate the effect of each sample concentration.

Secondary Outcome

Comparison with SDF rate of sperm after DGC
SDF rate (SCSA and TUNEL methods)

Comparison with detailed items obtained from semen/sperm tests
pH, LIN (linearity), STR (linearity), WOB (curvature), VAP (average velocity), VSL (curvature velocity), VCL (straight velocity), ALH (head amplitude value), BCF (number of head amplitudes), Head Length (length of sperm head), Head Width (width of sperm head), Head Perimeter (perimeter of sperm head), Head Area (area of sperm head), Tail Length (length of sperm tail)

Comparison of lifestyle factors
Age, height, weight, medical history, duration of abstinence, average hours of sleep, smoking habit, amount of smoking, drinking habit, amount of drinking, exercise habit, type of exercise, duration of exercise, health supplement consumption, type of health supplement consumed

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1) Male patients over 18 years old
2) Patients whose background can be confirmed in the medical records
3) Patients with a total sperm count of 3.333 x 10^7 or higher in the original semen
4) Patients who have given written consent to participate in the study

• Exclude criteria: Patients deemed inappropriate for inclusion in the study by the principal investigator or principal investigator

Related Information

• Primary Sponsor: Maezawa Tadashi