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NCT06990841 · ClinicalTrials.gov registry record · NA
Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development
A NA study of Sperm DNA Fragmentation and DNA Damage, sponsored by Richard Kordus, PhD, HCLD (ABB).
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06990841: Recruiting NA study of Sperm DNA Fragmentation and DNA Damage, sponsored by Richard Kordus, PhD, HCLD (ABB).
NCT06990841 is a NA study of Sperm DNA Fragmentation and DNA Damage that is actively recruiting participants, run by Richard Kordus, PhD, HCLD (ABB). The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06990841, a NA study of Sperm DNA Fragmentation and DNA Damage, is actively recruiting participants, sponsored by Richard Kordus, PhD, HCLD (ABB).
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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 nucleoi
Conditions Studied
Interventions
- DEVICE sperm separation device
Study Locations (1)
South Carolina
- Prisma Health-Upstate Fertility Center of the Caroliinas - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-08-11 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT06990841 shows while recruiting
NCT06990841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Sperm DNA Fragmentation appearing as the primary indexed condition, and to 1 intervention - of which sperm separation device is the first listed.
NCT06990841 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06990841 about?
NCT06990841 is a clinical study titled "Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm 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: 1. Does the LensHooke® CA0 device reduce DNA fragmentation compared to the gradient/swim-up techniqu...
What is the current status of trial NCT06990841?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2025-08-11. Estimated completion is 2026-12.
What conditions does trial NCT06990841 study?
This clinical trial studies the following conditions: Sperm DNA Fragmentation, DNA Damage, DNA Strand Breaks.
What interventions are being tested in trial NCT06990841?
The interventions under investigation include: sperm separation device (DEVICE).
Who is sponsoring clinical trial NCT06990841?
This trial is sponsored by Richard Kordus, PhD, HCLD (ABB), which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06990841 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06990841's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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