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Search / Trial NCT06990841

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

Launched by RICHARD KORDUS, PHD, HCLD (ABB) · May 17, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for processing sperm to see which one results in healthier sperm and better embryo development. The main goal is to compare the LensHooke® CA0 device with a traditional method known as gradient/swim-up technique. Researchers want to find out if the LensHooke device can reduce DNA damage in sperm, improve sperm quality (like how well they can swim), and ultimately lead to higher pregnancy rates.

To participate in this trial, women aged 18 to 34 whose male partners have a sperm concentration of at least 15 million sperm per milliliter are eligible. Both sperm processing methods will be tested on the same semen sample, and participants can expect to have half of their eggs fertilized using sperm from each technique. The study will look at how well the embryos develop and whether there’s a difference in pregnancy outcomes between the two groups. It’s important to note that women over 35, those with a history of recurrent pregnancy loss, or with lower egg reserves may not be eligible for this study.

Gender

ALL

Eligibility criteria

  • 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

About Richard Kordus, Phd, Hcld (Abb)

Richard Kordus, PhD, HCLD (ABB), is a distinguished clinical trial sponsor with extensive expertise in laboratory medicine and clinical research. With a robust background in molecular diagnostics and reproductive biology, Dr. Kordus is dedicated to advancing innovative therapeutic solutions through rigorous scientific inquiry and collaboration. His leadership in clinical trials emphasizes a commitment to high standards of quality and compliance, ensuring that research outcomes are both reliable and impactful. Dr. Kordus's contributions to the field are underpinned by a passion for improving patient care and outcomes through evidence-based practices.

Locations

Greenville, South Carolina, United States

Patients applied

0 patients applied

Trial Officials

Richard Kordus, PhD

Principal Investigator

Prisma Health-Upstate Fertility Center of the Carolinas

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported