RecruitingNot ApplicableNCT05978947

Microfluidic Chip Method Versus Density Gradient Centrifugation Method on Semen Parameters

Effect of Sperm Preparation by a Microfluidic Chip Method Versus a Density Gradient Centrifugation Method on Semen Parameters


Sponsor

Professor Ernest Hung-Yu Ng

Enrollment

80 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: MALE

Inclusion Criteria1

  • 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.

Exclusion Criteria2

  • Sperm concentration of the raw semen of less than 5 million motile sperm per ml
  • Men unable to provide an ejaculated semen sample

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Interventions

DEVICEZyMōt Multi 850µL 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.

DEVICEDensity Gradient Centrifugation Method

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).


Locations(1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

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NCT05978947


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