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RECRUITING
NCT06990841
NA

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

Sponsor: Richard Kordus, PhD, HCLD (ABB)

View on ClinicalTrials.gov

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.

Official title: A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development

Key Details

Gender

All

Age Range

18 Years - 34 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-11

Completion Date

2026-12

Last Updated

2025-09-17

Healthy Volunteers

Yes

Interventions

DEVICE

sperm separation device

comparison of DNA damage between the 2 interventions and subsequent embryo development and pregnancy rates

Locations (1)

Prisma Health-Upstate Fertility Center of the Caroliinas

Greenville, South Carolina, United States