Two sperm preparation methods to lower sperm DNA damage and improve embryo development
Official title: A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development
Run by Prisma Health-Upstate · NCT06990841 · Data updated 2026-11-12
This will test whether using the LensHooke CA0 device on partner sperm lowers DNA fragmentation and affects fertilization, embryo development, and pregnancy outcomes for couples undergoing ICSI.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 34 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Prisma Health-Upstate Academic / other |
| Locations | 1 site (Greenville, South Carolina) |
| Status | Recruiting |
| Started | August 11, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | December 2027 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT06990841 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are couples planning ICSI where the male partner's semen concentration is ≥15 million/mL, the female partner is 18–34 years old, and there are enough eggs to yield at least four fertilized embryos per preparation method.
✕Probably not a fit
Patients with sperm concentration below 15 million/mL, female partners over 35, or those with recurrent pregnancy loss or diminished ovarian reserve are excluded and unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants provide one semen sample that is split and processed by the LensHooke CA0 device and by a standard gradient/swim-up technique. Each half is analyzed for DNA fragmentation, concentration, motility, and morphology, and sibling oocytes are injected by ICSI with sperm from each preparation to compare fertilization and embryo development. The trial compares embryo outcomes and pregnancy rates between the two preparation techniques within the same couple. Eligible couples must meet sperm concentration and female age criteria and achieve sufficient fertilized eggs in each arm for analysis.
Why it matters
Potential benefit: If successful, the LensHooke CA0 method could reduce sperm DNA fragmentation and lead to improved embryo quality and higher pregnancy rates for couples using ICSI.
How similar studies have gone: Prior studies of microfluidic or advanced sperm-selection devices have sometimes shown reductions in sperm DNA fragmentation, but consistent evidence for improved embryo development or pregnancy rates is limited and mixed.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Prisma Health-Upstate Fertility Center of the Caroliinas
Greenville, South Carolina, United States Recruiting
Study contacts
- Principal investigator: Richard Kordus, PhD — Prisma Health-Upstate Fertility Center of the Carolinas
- Study coordinator: Richard J Kordus, PhD
- Email: rich.kordus@prismahealth.org
- Phone: 864-455-1675
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.