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

NCT06990841 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-17

No results posted yet for this study

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

Interventions

DEVICE

sperm separation device

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

Sponsors & Collaborators

  • Richard Kordus, PhD, HCLD (ABB)

    lead OTHER

Principal Investigators

  • Richard Kordus, PhD · Prisma Health-Upstate Fertility Center of the Carolinas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06990841 on ClinicalTrials.gov