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Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development

Richard Kordus, PhD, HCLD (ABB) · NCT06990841

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–34 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
1
Study start
August 11, 2025
Record last updated
September 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

  • Does the LensHooke® CA0 device reduce DNA fragmentation compared to the gradient/swim-up technique?
  • Does the LensHooke® CA0 device improve concentration, motility, and morphology compared to the gradient/swim-up technique?
  • Is sibling embryo fertilization and development the same?
  • 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.

Being studied: sperm separation device

Conditions: DNA Damage; DNA Strand Breaks; Sperm DNA Fragmentation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Prisma Health-Upstate Fertility Center of the Caroliinas

    Greenville, SC 29605

    Site contact: Richard J Kordus, PhD · 864-455-1675 · rich.kordus@prismahealth.org

Study contacts (from the official record)

  • Richard J Kordus, PhD · 864-455-1675 · rich.kordus@prismahealth.org
  • Patti Parker · 864-455-1510 · patti.parker@prismahealth.org
All healthy volunteers studies in South Carolina →
Comparison of Two Different Sperm Processing Methods and Their… (NCT06990841) | Bored Studies