RecruitingNot ApplicableNCT06990841

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

A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development


Sponsor

Richard Kordus, PhD, HCLD (ABB)

Enrollment

50 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 34 Years

Inclusion Criteria3

  • 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 Criteria4

  • Samples with \<15 M/mL spermatozoa concentration
  • female partner \>35 years old
  • female patient with recurrent pregnancy loss
  • female patient with diminished ovarian reserve

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Interventions

DEVICEsperm separation device

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


Locations(1)

Prisma Health-Upstate Fertility Center of the Caroliinas

Greenville, South Carolina, United States

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NCT06990841


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