Recruiting

LensHooke CA0 vs. Gradient

Sponsor:

Richard Kordus, PhD, HCLD (ABB)

Code:

NCT06990841

Conditions

DNA Damage

DNA Strand Breaks

Sperm DNA Fragmentation

Eligibility Criteria

Sex: All

Age: 18 - 34

Healthy Volunteers: Accepted

Interventions

sperm separation device

Study Details

Brief 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.

Conditions

DNA Damage

DNA Strand Breaks

Sperm DNA Fragmentation

Study ID

NCT06990841

Start date

Aug 11, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 34

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gradient/swim-up vs Lenshooke CA0 device comparison

Interventions

sperm separation device

comparison of DNA damage between the 2 interventions and subsequent embryo development and pregnancy rates

Primary outcome measure

  • Percentage of sperm with DNA fragmentation [ Time Frame: From enrollment until day after sample collection, approximately 1 month ]

Central Contacts and Locations

Central contacts

Richard J Kordus, PhD

864-455-1675rich.kordus@prismahealth.org

Patti Parker

864-455-1510patti.parker@prismahealth.org

Locations

Prisma Health-Upstate Fertility Center of the Caroliinas

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Richard J Kordus, PhD

864-455-1675rich.kordus@prismahealth.org

More Information

Sponsor

Richard Kordus, PhD, HCLD (ABB)

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Richard Kordus, PhD, HCLD (ABB) on 2025-09-17.