About this trial
Elevated SDF can adversely impact fertilization, embryo development, and pregnancy outcomes in IVF-ICSI cycles. Two pragmatic strategies aim to reduce SDF on the day of ICSI: (i) obtaining a second ejaculate shortly after the first to reduce oxidative damage and transit time; and (ii) selecting sperm via centrifugation-free sperm separation device, which enriches for motile sperm with intact DNA. There are limited direct comparisons between these strategies; this study addresses that gap.
Eligibility criteria
Qualifiers
• 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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Processed using density gradient centrifugation
- Second Ejaculate (collected after 1-3 hours)