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

NCT06990841 | Recruiting FDA Device

• 1 other identifier: 2295231-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the LensHooke® CA0 device reduce DNA fragmentation compared to the gradient/swim-up technique?
2. 2.Does the LensHooke® CA0 device improve concentration, motility, and morphology compared to the gradient/swim-up technique?
3. 3.Is sibling embryo fertilization and development the same?
4. 4.Are pregnancy rates different between the 2 groups?

Conditions

DNA Damage; DNA Strand Breaks; Sperm DNA Fragmentation

Outcome Measures

Primary Outcomes (1)

• Percentage of sperm with DNA fragmentation

  The method is based on the Sperm Chromatin Dispersion (SCD) test (Fernández et al., J. Androl 24:59-66, 2003; Fertil Steril 84:833-842, 2005). Intact unfixed spermatozoa (fresh, frozen/unthawed, diluted or neat samples) are immersed in an inert agarose microgel on a pretreated slide. An initial acid treatment denatures DNA in those sperm cells with fragmented DNA. Following this, the lysing solution removes most of the nuclear proteins, and in the absence of massive DNA breakage produces nucleoids with large halos of spreading DNA loops, emerging from a central core. However, the nucleoids from spermatozoa with fragmented DNA either do not show a dispersion halo or the halo is minimal. Slides are stained with Wright's stain. A minimum of 300 sperm per sample will be counted. The percentage of sperm with fragmented DNA will be calculated by dividing the sperm with small and no halos (fragmented sperm) by the total number of sperm counted.

  From enrollment until day after sample collection, approximately 1 month

Secondary Outcomes (1)

• Concentration of sperm per mL

  From enrollment until day after sample collection, approximately 1 month

Other Outcomes (6)

• Percentage of motile sperm

  From enrollment until day after sample collection, approximately 1 month

• Percentage of Sperm with normal morphology Using Kruger Strict Criteria

  From enrollment until day after sample collection, approximately 1 month

• Percentage of egg fertilization

  From enrollment until a week after sample collection, approximately 5 weeks

Study Arms (1)

Gradient/swim-up vs Lenshooke CA0 device comparison

EXPERIMENTAL

Device: sperm separation device

Interventions

sperm separation device DEVICE

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

Gradient/swim-up vs Lenshooke CA0 device comparison

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Richard Kordus, PhD, HCLD (ABB): lead

Study Sites (1)

Prisma Health-Upstate Fertility Center of the Caroliinas

Greenville, South Carolina, 29605, United States

RECRUITING

Related Publications (4)

• Ho CLT, Vaughan-Constable DR, Ramsay J, Jayasena C, Tharakan T, Yap T, Whiteman I, Graham N, Minhas S, Homa ST. The relationship between genitourinary microorganisms and oxidative stress, sperm DNA fragmentation and semen parameters in infertile men. Andrologia. 2022 Mar;54(2):e14322. doi: 10.1111/and.14322. Epub 2021 Nov 24.

  PMID: 34817086 BACKGROUND

• Amor H, Hammadeh ME, Mohd I, Jankowski PM. Impact of heavy alcohol consumption and cigarette smoking on sperm DNA integrity. Andrologia. 2022 Aug;54(7):e14434. doi: 10.1111/and.14434. Epub 2022 Apr 28.

  PMID: 35484935 BACKGROUND

• Cho CL, Agarwal A, Majzoub A, Esteves SC. Clinical utility of sperm DNA fragmentation testing: concise practice recommendations. Transl Androl Urol. 2017 Sep;6(Suppl 4):S366-S373. doi: 10.21037/tau.2017.07.28.

  PMID: 29082146 BACKGROUND

• Rex AS, Aagaard J, Fedder J. DNA fragmentation in spermatozoa: a historical review. Andrology. 2017 Jul;5(4):622-630. doi: 10.1111/andr.12381.

  PMID: 28718529 BACKGROUND

Study Officials

• Richard Kordus, PhD

  Prisma Health-Upstate Fertility Center of the Carolinas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard J Kordus, PhD

CONTACT

864-455-1675; rich.kordus@prismahealth.org

Patti Parker

CONTACT

864-455-1510; patti.parker@prismahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of ART Laboratories

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 25, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)