Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development

Richard Kordus, PhD, HCLD (ABB)

Status: Enrolling

Conditions: Sperm DNA Fragmentation; DNA Damage; DNA Strand Breaks

Treatments: Device: sperm separation device

Study type: Interventional

Funder types: Other

Identifiers

NCT06990841

2295231-1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Gradient/swim-up vs Lenshooke CA0 device comparison

Experimental group

Treatment:

Device: sperm separation device