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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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DNA Damage DNA Strand Breaks Sperm DNA Fragmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gradient/swim-up vs Lenshooke CA0 device comparison

Group Type EXPERIMENTAL

sperm separation device

Intervention Type DEVICE

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

Interventions

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sperm separation device

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes