DNA DamageNCT06990841
Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development
A study testing sperm separation device in people with DNA Damage and DNA Strand Breaks, run by Richard Kordus, PhD, HCLD (ABB) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- DNA Damage, DNA Strand Breaks, Sperm DNA Fragmentation
- What is being tested?
- sperm separation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Samples with <15 M/mL spermatozoa concentration
- female partner >35 years old
- female patient with recurrent pregnancy loss
- female patient with diminished ovarian reserve
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prisma Health-Upstate Fertility Center of the Caroliinas
Greenville, South Carolina, 29605
Richard J Kordus, PhD, 864-455-1675, rich.kordus@prismahealth.org
About this study
Official title: A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development
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:
Read more
- Does the LensHooke® CA0 device reduce DNA fragmentation compared to the gradient/swim-up technique?
- Does the LensHooke® CA0 device improve concentration, motility, and morphology compared to the gradient/swim-up technique?
- Is sibling embryo fertilization and development the same?
- 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
- DNA Damage, DNA Strand Breaks, Sperm DNA Fragmentation
- Being tested
- sperm separation device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sperm separation deviceDevice
comparison of DNA damage between the 2 interventions and subsequent embryo development and pregnancy rates
| Study group | Role | What they receive |
|---|---|---|
| Gradient/swim-up vs Lenshooke CA0 device comparison | Experimental | Not described Receives: Device: sperm separation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until day after sample collection, approximately 1 month
Secondary outcomes (1)
Concentration of sperm per mL
Assessed using a sperm class analyzer - SCA (CASA system) for sperm count. Semen samples will be loaded into 20 microliter depth fixed volume slides. Slides will be placed on the Microoptics SCA machine. Videos will be captured of fields until at least 200 motile sperm are captured. Concentration will be analyzed by counting the number of sperm within each field, corrected for the depth of the chamber, and multipled by the volume of the sample. Concentrations between fields will not vary by more than 15%.
Measured: From enrollment until day after sample collection, approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start11 Aug 2025
- Primary completion30 Sep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DNA DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richard Kordus, PhD, HCLD (ABB)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Kordus, PhD, HCLD (ABB), Prisma Health-Upstate
- Investigators
- Richard Kordus, PhD, Principal investigator, Prisma Health-Upstate Fertility Center of the Carolinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990841
- Sponsor's protocol ID
- 2295231-1
- Status last verified
- Sep 2026
- First submitted
- 8 May 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34817086Amor 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.
PubMed 35484935Cho 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.
PubMed 29082146Rex AS, Aagaard J, Fedder J. DNA fragmentation in spermatozoa: a historical review. Andrology. 2017 Jul;5(4):622-630. doi: 10.1111/andr.12381.
PubMed 28718529
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development
- ClinicalTrials.gov ID
- NCT06990841
- Acronym / sponsor ID
- 2295231-1
- Conditions
- DNA Damage, DNA Strand Breaks, Sperm DNA Fragmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Richard Kordus, PhD, HCLD (ABB)University, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the LensHooke® CA0 device reduce DNA fragmentation compared to the gradient/swim-up technique?
- Does the LensHooke® CA0 device improve concentration, motility, and morphology compared to the gradient/swim-up technique?
- Is sibling embryo fertilization and development the same?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gradient/swim-up vs Lenshooke CA0 device comparison | Experimental | Device: sperm separation device |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Samples with <15 M/mL spermatozoa concentration
- female partner >35 years old
- female patient with recurrent pregnancy loss
- female patient with diminished ovarian reserve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sperm separation devicecomparison of DNA damage between the 2 interventions and subsequent embryo development and pregnancy rates | Device | Gradient/swim-up vs Lenshooke CA0 device comparison |
Primary outcome
Percentage of sperm with DNA fragmentation
Time frame: From enrollment until day after sample collection, approximately 1 month
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.
1 secondary outcome
Concentration of sperm per mL
Time frame: From enrollment until day after sample collection, approximately 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 34817086Ho 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.
- Background: PubMed 35484935Amor 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.
- Background: PubMed 29082146Cho 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.
- Background: PubMed 28718529Rex AS, Aagaard J, Fedder J. DNA fragmentation in spermatozoa: a historical review. Andrology. 2017 Jul;5(4):622-630. doi: 10.1111/andr.12381.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Kordus, PhD principal investigator
Prisma Health-Upstate Fertility Center of the Carolinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sperm separation device in people with DNA Damage and DNA Strand Breaks, run by Richard Kordus, PhD, HCLD (ABB) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard J Kordus, PhD (864-455-1675, rich.kordus@prismahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of sperm with DNA fragmentation (time frame: From enrollment until day after sample collection, approximately 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06990841, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.