Two sperm preparation methods to lower sperm DNA damage and improve embryo development
A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development
NA · Prisma Health-Upstate · NCT06990841
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 34 Years |
| Sex | All |
| Sponsor | Prisma Health-Upstate (other) |
| Locations | 1 site (Greenville, South Carolina) |
| Trial ID | NCT06990841 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Greenville, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: DNA Damage, DNA Strand Breaks, Sperm DNA Fragmentation