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.

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.

NCT Number	NCT07626359
Lead Sponsor	Indira IVF Hospital Pvt Ltd
Conditions	Male
Enrollment	830 participants
Start Date	2026-08-05
Primary Completion	2027-12-25 (estimated)
Study Completion	2028-03-25 (estimated)
Updated on ClinicalTrials.gov	2026-06-04