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Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development
Sponsor: Richard Kordus, PhD, HCLD (ABB)
Summary
The goal of this clinical trial is to learn if the LensHooke CA0 device lowers DNA fragmentation in sperm samples compared to a gradient/swim-up technique. The main questions it aims to answer are: 1. Does the LensHooke® CA0 device reduce DNA fragmentation compared to the gradient/swim-up technique? 2. Does the LensHooke® CA0 device improve concentration, motility, and morphology compared to the gradient/swim-up technique? 3. Is sibling embryo fertilization and development the same? 4. Are pregnancy rates different between the 2 groups? 1 semen sample will be split between the 2 treatment techniques. Half of the partner's egg cohort will be injected via intra-cytoplasmic sperm using sperm processed by one technique and the other half of the cohort will be injected by the sperm processed by the other technique. Both methods will look at DNA fragmentation, concentration, motility, and morphology of the sperm. Both methods will be compared in the resulting embryos looking at fertilization, embryo development and pregnancy rates.
Official title: A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development
Key Details
Gender
All
Age Range
18 Years - 34 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-08-11
Completion Date
2026-12
Last Updated
2025-09-17
Healthy Volunteers
Yes
Interventions
sperm separation device
comparison of DNA damage between the 2 interventions and subsequent embryo development and pregnancy rates
Locations (1)
Prisma Health-Upstate Fertility Center of the Caroliinas
Greenville, South Carolina, United States