Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development
A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development
- DNA Damage
- DNA Strand Breaks
- Sperm DNA Fragmentation
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Richard Kordus, PhD, HCLD (ABB)
- Enrolment target
- 50
- Started
- 11 August 2025
- Main results due
- 30 September 2027
- Study sites
- 1
- Registry updated
- 24 September 2026
Can you take part?
- Ages 18 years to 34 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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
What this study is about
In the sponsor’s own words, from the registry.
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. Does the LensHooke® CA0 device improve concentration, motility, and morphology compared to the gradient/swim-up technique? 3. Is sibling embryo fertilization and development the same? 4. 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 sites(1)
Prisma Health-Upstate Fertility Center of the Caroliinas
Greenville, South Carolina, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06990841. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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