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- study protocol.

Background: Pathological sperm DNA fragmentation (SDF) has been associated with impaired fertilization, compromised embryo development, recurrent pregnancy loss, and lower pregnancy rates in assisted reproductive technology (ART). Two same-day strategies proposed to reduce SDF prior to Methods and analysis: This prospective, multicenter, within-patient, sibling-oocyte randomized non-inferiority trial will be conducted at nine tertiary ART centers in India. Couples undergoing ICSI will be eligible if the male partner is aged 21-45 years with elevated SDF (DNA fragmentation index >20% by sperm chromatin dispersion assay within 90 days before enrollment) and the female partner is aged 21-35 years and expected to yield at least four metaphase II oocytes. On the day of oocyte retrieval, the first ejaculate collected after 2-3 days of abstinence will undergo processing using the LensHooke Ethics and dissemination: The study protocol has been approved by the institutional review boards of all participating centers. Written informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed publications and scientific meetings. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT07626359.