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.
• 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.
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
Crossover
Processed using density gradient centrifugation
Procedure/SurgeryProcessed using density gradient centrifugation
Second Ejaculate (collected after 1-3 hours)
Procedure/SurgeryThe second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.
Ongoing Pregnancy Rate
Ongoing pregnancy rate
Sperm motility and morphology after sperm sorting or second ejaculate collection.
Sperm motility and morphology after sperm sorting or second ejaculate collection.
Blastocyst rate
Blastocyst rate
Good Blastocyst rate
Total number of good blast
Biochemical Pregnancy Rate
Biochemical Pregnancy Rate
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
