Sperm Separation Device for Sperm DNA Fragmentation

Overseen By Patti Parker

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Richard Kordus, PhD, HCLD (ABB)

Disqualifiers: Low sperm concentration, Partner over 35, Recurrent pregnancy loss, Diminished ovarian reserve

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the LensHooke CA0 device, a sperm separation tool, can better prepare sperm for pregnancy by reducing DNA fragmentation, which can affect fertility. Researchers will compare this new device to the current gradient/swim-up technique to identify which method results in healthier sperm and improved pregnancy outcomes. Men with a sperm concentration of 15 million per milliliter or higher, along with their female partners aged 18-34 who can provide at least eight fertilized eggs for testing, may be suitable candidates for this study. As an unphased trial, participants have the opportunity to contribute to innovative fertility research that could enhance future pregnancy outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the LensHooke CA0 device is safe for sperm DNA fragmentation?

Research has shown that the LensHooke CA0 device prepares sperm for fertility treatments such as ICSI (injecting sperm directly into an egg), IVF (fertilizing an egg outside the body), and IUI (placing sperm directly into the uterus). The device aims to enhance sperm quality by reducing DNA damage.

In one study, the LensHooke CA0 device reduced sperm DNA damage from 46% to a lower level, suggesting potential improvements in sperm quality. However, specific safety information or reports on side effects for humans using this device are not clearly provided.

The trial is labeled "Not Applicable" for a phase, indicating it may be more exploratory or observational, rather than focused on safety testing like other clinical studies. Nonetheless, the device's use in fertility treatments suggests it is generally considered safe for this purpose.

Overall, while the LensHooke CA0 device appears promising for improving sperm quality, detailed safety data from trials is not available. Participants should consult healthcare providers about potential risks and benefits before joining a trial involving this device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The LensHooke CA0 device is unique because it offers a new way to address sperm DNA fragmentation by using advanced sperm separation techniques. Traditional methods like gradient centrifugation or swim-up procedures rely on physical or chemical separation, which might not effectively reduce DNA fragmentation. The LensHooke CA0 device aims to enhance the selection of healthier sperm with intact DNA, potentially improving fertility outcomes. Researchers are excited because this device could lead to more successful pregnancies for couples facing infertility challenges linked to sperm DNA damage.

What evidence suggests that the LensHooke CA0 device is effective for reducing sperm DNA fragmentation?

Research has shown that the LensHooke CA0 device can help reduce damage to sperm DNA. One study found that sperm DNA damage decreased from 46% to lower levels with this device. This reduction is important because less DNA damage usually indicates healthier sperm. The device also improves sperm motility. In this trial, participants will compare the LensHooke CA0 device with traditional gradient/swim-up methods. The LensHooke CA0 device has demonstrated higher movement rates than traditional methods, suggesting it could lead to better outcomes in fertility treatments. ^{2 3 6 7 8}

Who Is on the Research Team?

Richard Kordus, PhD

Principal Investigator

Prisma Health-Upstate Fertility Center of the Carolinas

Are You a Good Fit for This Trial?

This trial is for individuals providing a semen sample, likely those experiencing fertility issues. The study will compare two sperm processing methods using their samples. Specific eligibility details are not provided, so general participation criteria cannot be summarized.

Inclusion Criteria

Samples with ≥15 M/mL spermatozoa concentration

My female partner is 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

My female partner is over 35 years old.

I am a woman who has experienced multiple miscarriages.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Semen samples are split and processed using two different techniques: LensHooke CA0 device and gradient/swim-up technique. The processed sperm is used for intra-cytoplasmic sperm injection and embryo development is monitored.

5 weeks

Follow-up

Participants are monitored for embryo development, fertilization rates, and pregnancy outcomes.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• LensHooke CA0 device

Trial Overview The trial tests if the LensHooke CA0 device can reduce DNA fragmentation in sperm better than the traditional gradient/swim-up technique and improve other sperm qualities like concentration, motility, and morphology.

How Is the Trial Designed?

Group I: Gradient/swim-up vs Lenshooke CA0 device comparison Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Richard Kordus, PhD, HCLD (ABB)

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12156501/

A Case Study on Overcoming Male Infertility Using the ... The use of the LensHooke CA0 device, a centrifugation-free sperm separation technology, effectively reduced sperm DNA fragmentation from 46% to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06956287

NCT06956287 | The Efficiency of a New Sperm-Wash ... The outcome aims to evaluate the effectiveness of the novel sperm-wash device (LensHooke CA0) compared to conventional density gradient centrifugation (DGC) in ...

3. febs.onlinelibrary.wiley.com febs.onlinelibrary.wiley.com/doi/10.1002/2211-5463.70073

Functional parameters of spermatozoa obtained by a new ... In this work, we examined the use of the LensHooke CA0™ device (CA0 chamber) as a promising sperm separation method for ARTs, analyzing both ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10371955/

Live motile sperm sorting device for enhanced ... In paired analysis, CA0 showed significantly higher total motility (94.0%), progressive motility (90.8%), rapid progressive motility (83.6%), ...

5. trial.medpath.com trial.medpath.com/clinical-trial/f219fe3249b2090c/nct06990841-sperm-preparation-dna-fragmentation-embryo-development

Comparison of Two Different Sperm Processing Methods and ... The goal of this clinical trial is to learn if the LensHooke CA0 device lowers DNA fragmentation in sperm samples compared to a ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221810.pdf

K221810.pdf - accessdata.fda.gov The LensHooke CAO and CAI Sperm Separation Devices are for preparing motile sperm for ICSI, IVF, and IUI procedures for infertile couples.

7. lenshooke.com lenshooke.com/products.php

Products LensHooke offers semen quality analyzers, morphology slides, DNA fragmentation test kits, and data consolidation software.

8. trialx.com trialx.com/clinical-trials/listings/314870/comparison-of-two-different-sperm-processing-methods-and-their-effects-on-sperm-dna-fragmentation-and-embryo-development/

Clinical Research Trial Listing ( Sperm DNA Fragmentation 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 ...