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

Part of paid clinical trials in Greenville, South Carolina.

Sponsor
Richard Kordus, PhD, HCLD (ABB)
Study ID
NCT06990841
Status
Recruiting
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Conditions

  • DNA Damage
  • DNA Strand Breaks
  • Sperm DNA Fragmentation

Eligibility Criteria

Sex
ALL
Age
18 Years - 34 Years
Healthy Volunteers
Accepted

Interventions

  • sperm separation device — DEVICE
    comparison of DNA damage between the 2 interventions and subsequent embryo development and pregnancy rates

Study Details

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.

Key Dates

Start date
Aug 11, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gradient/swim-up vs Lenshooke CA0 device comparison

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Prisma Health-Upstate Fertility Center of the CaroliinasGreenvilleSouth Carolina29605
Richard J Kordus, PhD
[email protected]
864-455-1675

Find similar trials in Greenville, SC

By research site
Prisma Health-Upstate Fertility Center of the Caroliinas· Greenville, SC

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