Comparing Sperm Processing Methods for DNA Fragmentation and Embryo Development

This study is comparing two ways to prepare sperm: the LensHooke CA0 device and a standard gradient/swim-up technique. Researchers want to see if the LensHooke CA0 device can reduce DNA fragmentation (damage to sperm DNA) and improve sperm quality. They will also look at how well embryos develop and if pregnancy rates are different between the two methods. You may be able to join if you are a male between 18 and 34 years old with a sperm concentration of at least 15 million/mL, and your female partner is between 18 and 34 years old. The study aims to enroll 50 participants.

Study design
This interventional study will involve 50 participants. One semen sample from each participant will be split and treated with both techniques for comparison.
What's involved
You will provide one semen sample, which will then be split and processed using two different techniques. The study will measure DNA fragmentation and observe embryo development.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, percentage of sperm with DNA fragmentation, will be measured from enrollment until approximately one month after sample collection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06990841

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

Recruiting
NAAges 18–34InterventionalTreatment
Richard Kordus, PhD, HCLD (ABB)
~50 participants
Updated 2025-09-17 on ClinicalTrials.gov
What's tested:sperm separation device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of sperm with DNA fragmentation
Measured over From enrollment until day after sample collection, approximately 1 month
DNA Damage
DNA Strand Breaks
Sperm DNA Fragmentation
1 sites across 1 states
South Carolina1
  • Richard Kordus, PhD · PRINCIPAL_INVESTIGATOR · Prisma Health-Upstate Fertility Center of the Carolinas

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Samples with \<15 M/mL spermatozoa concentration
female partner \>35 years old
female patient with recurrent pregnancy loss
female patient with diminished ovarian reserve
  • Percentage of sperm with DNA fragmentationFrom enrollment until day after sample collection, approximately 1 month

    The method is based on the Sperm Chromatin Dispersion (SCD) test (Fernández et al., J. Androl 24:59-66, 2003; Fertil Steril 84:833-842, 2005). Intact unfixed spermatozoa (fresh, frozen/unthawed, diluted or neat samples) are immersed in an inert agarose microgel on a pretreated slide. An initial acid treatment denatures DNA in those sperm cells with fragmented DNA. Following this, the lysing solution removes most of the nuclear proteins, and in the absence of massive DNA breakage produces nucleoids with large halos of spreading DNA loops, emerging from a central core. However, the nucleoids from spermatozoa with fragmented DNA either do not show a dispersion halo or the halo is minimal. Slides are stained with Wright's stain. A minimum of 300 sperm per sample will be counted. The percentage of sperm with fragmented DNA will be calculated by dividing the sperm with small and no halos (fragmented sperm) by the total number of sperm counted.