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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.
Sponsor: Indira IVF Hospital Pvt Ltd
Summary
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.
Key Details
Gender
All
Age Range
21 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
830
Start Date
2026-10-05
Completion Date
2028-03-25
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Processed using density gradient centrifugation
Processed using density gradient centrifugation
Second Ejaculate (collected after 1-3 hours)
The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.
Locations (9)
Recruitment
Patna, Bihar, India
Indira IVF Hospital Limited
Bangalore, Karnataka, India
Recruitment
Bhāndup, Maharashtra, India
Recruitment
Pune, Maharashtra, India
Recruitment
Delhi, National Capital Territory of Delhi, India
Recruitment
Jaipur, Rajasthan, India
LAB
Udaipur, Rajasthan, India
Recruitment
Allahābād, Uttar Pradesh, India
Recruitment
Lucknow, Uttar Pradesh, India