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Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development
A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development
Who can join
Ages 18 to 34 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Samples with ≥15 M/mL spermatozoa concentration * Female partner between 18 and 34 years old. * Minimum of 4 fertilized eggs in gradient/swim prep group and 4 fertilized eggs in the Lenshooke prep group for each patient Exclusion Criteria: * Samples with \<15 M/mL spermatozoa concentration * female partner \>35 years old * female patient with recurrent pregnancy loss * female patient with diminished ovarian reserve
About the study
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.
What is being tested
- sperm separation device (device)
Sponsor: Richard Kordus, PhD, HCLD (ABB) · Participants: 50 · Started: Aug 11, 2025
Contact the study team
- Richard J Kordus, PhD · Phone: 864-455-1675
- Patti Parker · Phone: 864-455-1510
Official record on ClinicalTrials.gov — NCT06990841
Locations in the U.S.
| South Carolina | Prisma Health-Upstate Fertility Center of the Caroliinas, Greenville |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.