RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-08-11
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06990841

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 34 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Samples with ≥15 M/mL spermatozoa concentration
  2. * Female partner between 18 and 34 years old.
  3. * Minimum of 4 fertilized eggs in gradient/swim prep group and 4 fertilized eggs in the Lenshooke prep group for each patient
  1. * Samples with \<15 M/mL spermatozoa concentration
  2. * female partner \>35 years old
  3. * female patient with recurrent pregnancy loss
  4. * female patient with diminished ovarian reserve

Contacts and Locations

Study Contact

Richard J Kordus, PhD
CONTACT
864-455-1675
rich.kordus@prismahealth.org
Patti Parker
CONTACT
864-455-1510
patti.parker@prismahealth.org

Principal Investigator

Richard Kordus, PhD
PRINCIPAL_INVESTIGATOR
Prisma Health-Upstate Fertility Center of the Carolinas

Study Locations (Sites)

Prisma Health-Upstate Fertility Center of the Caroliinas
Greenville, South Carolina, 29605
United States

Collaborators and Investigators

Sponsor: Richard Kordus, PhD, HCLD (ABB)

  • Richard Kordus, PhD, PRINCIPAL_INVESTIGATOR, Prisma Health-Upstate Fertility Center of the Carolinas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-08-11
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • DNA Damage
  • DNA Strand Breaks
  • Sperm DNA Fragmentation