Actively Recruiting

Phase Not Applicable
Age: 18Years - 34Years
All Genders
Healthy Volunteers
ID06990841

Comparison of Two Sperm Preparation Techniques on DNA Fragmentation and Embryo Development

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

50

Participants Needed

1

Research Sites

22 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether the LensHooke CA0 device can lower DNA fragmentation in sperm samples compared to the traditional gradient/swim-up technique. The study aims to answer key questions about sperm quality, including DNA fragmentation, concentration, motility, and morphology. It also looks at fertilization, embryo development, and pregnancy rates between the two sperm processing methods. Participants will provide one semen sample, which will be split and processed using both the LensHooke CA0 device and the gradient/swim-up technique. Half of the female partner's eggs will be fertilized using sperm prepared by one method, and the other half with sperm from the other method. Outcomes such as DNA damage, sperm concentration, and embryo development will be compared between these two approaches. During the study, researchers will measure the percentage of sperm with DNA fragmentation and sperm concentration from enrollment until about one month after sample collection. They will also monitor embryo fertilization, development, and pregnancy rates. This trial involves follow-up assessments around the time of fertilization and embryo development to track the impact of each sperm processing technique.

CONDITIONS

Brief 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 15 million spermatozoa per milliliter concentration
  • Female partner aged between 18 and 34 years old
  • Minimum of 4 fertilized eggs in the gradient/swim-up group and 4 fertilized eggs in the LensHooke group for each patient
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Approximately 1 month

Participants provide sperm samples which are processed using two different sperm preparation techniques to compare DNA fragmentation and subsequent embryo development.

1 visit for sample collection (in-person)

Trial Site Locations

Total: 1 location

1

Prisma Health-Upstate Fertility Center of the Caroliinas

Greenville, South Carolina, United States, 29605

Actively Recruiting

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Research Team

R

Richard J Kordus, PhD

P

Patti Parker

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

The relationship between genitourinary microorganisms and oxidative stress, sperm DNA fragmentation and semen parameters in infertile men.

Carmen Lok Tung Ho, Daniella R Vaughan-Constable, Jonathan Ramsay...

https://pubmed.ncbi.nlm.nih.gov/34817086