Microfluidic Chip Method Versus Density Gradient Centrifugation Method on Semen Parameters

ConditionInfertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorProfessor Ernest Hung-Yu Ng

About this trial

Infertility affects many couples, with male infertility being a common cause. In vitro fertilization (IVF) is an effective treatment, but its success rates are not high. Semen quality can affect IVF outcomes, and the current method used to process semen can damage the sperm and DNA. Scientists are now testing a new method called microfluidic chip technology, which reduces DNA damage and increases sperm movement. This study will compare the effectiveness of the chip method and the current method on semen quality in men attending a fertility clinic. The study will randomly assign semen collected to one of the two methods and assess the semen quality using different tests, as well as the difference in using two different microfluidic chip platform . The primary outcome will be DNA fragmentation, and other outcomes include sperm count and motility. Semen samples would be collected from study subjects for analysis and that both the samples and results would not be used in patients' treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Sperm concentration of the raw semen with at least 5 million motile sperm per ml with a total volume of not less than 1.5ml.

Disqualifiers

Sperm concentration of the raw semen of less than 5 million motile sperm per ml

Men unable to provide an ejaculated semen sample

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZyMōt Multi 850µL device

    Device

    The ZyMōt Multi 850µL device is a laboratory tool designed for use in assisted reproductive technology (ART) procedures such as intrauterine insemination (IUI) and in vitro fertilization (IVF). It is a sperm preparation device that uses a proprietary patented technology to isolate and select motile sperm from semen samples for use in ART procedures.

  • Density Gradient Centrifugation Method

    Device

    Density gradient centrifugation is a laboratory technique used to separate and isolate different types of cells or particles based on their density. It is commonly used in various applications, including cell biology, immunology, and assisted reproductive technology (ART).

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Microfluidic Chip MethodExperimental treatment 1 intervention
Group B: Density Gradient Centrifugation MethodActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

DNA fragmentation by Comet assay

Measurement of DNA fragmentation by Comet assay using the Olive tail moment as the quantitative metric.

Time frame
1 months

Secondary outcomes

1

Sperm count

Sperm count

Time frame
1 months
2

Forward motility

Assessment of forward motility of sperm by manual observation using the World Health Organization (WHO) criteria.

Time frame
1 months
3

Sperm velocities measured by CASA

Quantitative analysis of sperm velocities using computer-assisted sperm analysis (CASA) system, including assessment of forward motility, curvilinear velocity, and linearity.

Time frame
1 months
4

Morphology

Quantitative assessment of sperm morphology by manual observation using the Tygerberg strict criteria.

Time frame
1 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Professor Ernest Hung-Yu Ng

Lead sponsor

The University of Hong Kong

Sponsor institution