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

September 10, 2025 updated by: Richard Kordus, PhD, HCLD (ABB)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gradient/swim-up vs Lenshooke CA0 device comparison
Device: sperm separation device
comparison of DNA damage between the 2 interventions and subsequent embryo development and pregnancy rates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of sperm with DNA fragmentation
Time Frame: From enrollment until day after sample collection, approximately 1 month
The method is based on the Sperm Chromatin Dispersion (SCD) test (Fernández et al., J. Androl 24:59-66, 2003; Fertil Steril 84:833-842, 2005). Intact unfixed spermatozoa (fresh, frozen/unthawed, diluted or neat samples) are immersed in an inert agarose microgel on a pretreated slide. An initial acid treatment denatures DNA in those sperm cells with fragmented DNA. Following this, the lysing solution removes most of the nuclear proteins, and in the absence of massive DNA breakage produces nucleoids with large halos of spreading DNA loops, emerging from a central core. However, the nucleoids from spermatozoa with fragmented DNA either do not show a dispersion halo or the halo is minimal. Slides are stained with Wright's stain. A minimum of 300 sperm per sample will be counted. The percentage of sperm with fragmented DNA will be calculated by dividing the sperm with small and no halos (fragmented sperm) by the total number of sperm counted.
From enrollment until day after sample collection, approximately 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of sperm per mL
Time Frame: From enrollment until day after sample collection, approximately 1 month
Assessed using a sperm class analyzer - SCA (CASA system) for sperm count. Semen samples will be loaded into 20 microliter depth fixed volume slides. Slides will be placed on the Microoptics SCA machine. Videos will be captured of fields until at least 200 motile sperm are captured. Concentration will be analyzed by counting the number of sperm within each field, corrected for the depth of the chamber, and multipled by the volume of the sample. Concentrations between fields will not vary by more than 15%.
From enrollment until day after sample collection, approximately 1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of motile sperm
Time Frame: From enrollment until day after sample collection, approximately 1 month
Assessed using a sperm class analyzer - SCA (CASA system) for sperm motility. Semen samples will be loaded into 20 microliter depth fixed volume slides. Slides will be placed on the Microoptics SCA machine. Videos will be captured of fields until at least 200 motile sperm are captured. Motility will be calculated as the number of motile sperm counted divided by the total number of sperm counted. Types of motility will be noted according to WHO semen analysis groupings, hyperactivation, and kinetic motion parameters.
From enrollment until day after sample collection, approximately 1 month
Percentage of Sperm with normal morphology Using Kruger Strict Criteria
Time Frame: From enrollment until day after sample collection, approximately 1 month
10 uL volumes of sperm samples will be placed on pre-stained morphology slides using methylene blue/cresyl violet stain. A minimum of 200 sperm will be counted and assessed for normal vs abnormal sperm morphology using Kruger strict criteria. Percentage of normal sperm will be assessed my dividing the number of normal sperm by the total number of sperm counted.
From enrollment until day after sample collection, approximately 1 month
Percentage of egg fertilization
Time Frame: From enrollment until a week after sample collection, approximately 5 weeks
The number of fertilized eggs (zygotes) will be divided by the number of eggs inseminated
From enrollment until a week after sample collection, approximately 5 weeks
Numerical score of morphokinetic embryo development
Time Frame: From enrollment until a week after sample collection, approximately 5 weeks
Embryo development will be monitored using a time-lapse incubator. A score will be generated based on when the embryos meets developmental time points. The embryo will receive 2 points for each time point it successfully completes with expected parameters. Embryos will receive 1 point for each time point it completes but outside the expected time parameters. i.e. if an embryo has the first cleavage between 23-25 hours it will receive 2 points. If it cleaves earlier than 23 hours or later than 25 hours it will receive 1 point. The total score an embryo receives will be tallied from the time of insemination until the embryo is frozen.
From enrollment until a week after sample collection, approximately 5 weeks
Qualitative embryo grade
Time Frame: From enrollment until a week after sample collection, approximately 5 weeks
All embryos will be graded according to a 3-part grading scale at the time of cryopreservation between days 5 and 7 of culture. The embryo will be given a number score of 1-6 based on the embryo's size, size of the blastocoel fluid cavity, and whether or not it is inside, hatching out, or completely hatched out the zona. Each embryo will get a letter grade for the quality of the inner cell mass either A, B, C, or D. Each embryo will get a second letter grade for the quality of the trophectoderm A, B, C, or D.
From enrollment until a week after sample collection, approximately 5 weeks
Percentage of patients that become pregnant and deliver a baby
Time Frame: From enrollment until a delivery of infant, up to 18 months
Calculated by the number of patients that become pregnant (assessed by the presence of a fetal heartbeat 5-6 weeks following embryo transfer) divided by the total number of embryos transferred. Live birth will be calculated by the number of patients that give birth divided by the number of embryos transferred.
From enrollment until a delivery of infant, up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Richard Kordus, PhD, HCLD (ABB)

Investigators

  • Principal Investigator: Richard Kordus, PhD, Prisma Health-Upstate Fertility Center of the Carolinas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

August 11, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 8, 2025

First Submitted That Met QC Criteria

May 17, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2295231-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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