Actively Recruiting

Phase Not Applicable
Age: 18Years - 34Years
All Genders
Healthy Volunteers
NCT06990841

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

Led by Richard Kordus, PhD, HCLD (ABB) · Updated on 2025-09-17

50

Participants Needed

1

Research Sites

68 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 34Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Samples with at least 15 million sperm per milliliter concentration
  • Female partner aged between 18 and 34 years
  • Minimum of 4 fertilized eggs in the gradient/swim-up group and 4 fertilized eggs in the LensHooke preparation group for each patient
Not Eligible

You will not qualify if you...

  • Samples with less than 15 million sperm per milliliter concentration
  • Female partner older than 35 years
  • Female partner with recurrent pregnancy loss
  • Female partner with diminished ovarian reserve

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Prisma Health-Upstate Fertility Center of the Caroliinas

Greenville, South Carolina, United States, 29605

Actively Recruiting

Loading map...

Research Team

R

Richard J Kordus, PhD

CONTACT

P

Patti Parker

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here