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

Trial Summary

What is the purpose of this trial?

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.

Research Team

Richard Kordus, PhD

Principal Investigator

Prisma Health-Upstate Fertility Center of the Carolinas

Eligibility Criteria

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

My female partner is between 18 and 34 years old.

Samples with ≥15 M/mL spermatozoa concentration

Minimum of 4 fertilized eggs in gradient/swim prep group and 4 fertilized eggs in the Lenshooke prep group for each patient

Exclusion Criteria

My female partner is over 35 years old.

I am a woman who has experienced multiple miscarriages.

Samples with <15 M/mL spermatozoa concentration

Timeline

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

Treatment Details

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.

Participant Groups

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