Randomized Non-inferiority Within-Patient Trial of Density Gradient Processing of Sequential Ejaculates Versus Centrifugation-free Sperm Separation Device for ICSI in Men With Elevated Sperm DNA Fragmentation.

Inclusion criteria

• • Elevated SDF defined as DFI >20 %measured by the sperm chromatin dispersion (SCD) test performed in a participating center's andrology laboratory, using a harmonized protocol under standardized conditions after 2-3 days of ejaculatory abstinence, and within 90 days (≤3 months) prior to enrollment.

• Male partners 21-45 years;
• Female partners 21-35 years.
• Undergoing IVF/ICSI.
• No known genetic or chromosomal abnormalities.
• Minimum 4 MII oocyte patients shall be included

Exclusion criteria

• Azoospermia or severe oligoasthenozoospermia (<1 million motile sperm/mL).
• Significant systemic disease (e.g., uncontrolled diabetes, malignancy).
• History of a prior ICSI cycle with no embryo development.
• Relevant female factors: untreated adnexal pathology ,a history of a thin endometrium (<7 mm) following endometrium preparation for embryo transfer