Microfluidic Chip Method Versus Density Gradient Centrifugation Method on Semen Parameters

NCT05978947 | Recruiting FDA Device

• 1 other identifier: UW 23-233
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

Semen parameters; Microfluidic chip; Density Gradient Centrifugation

Outcome Measures

Primary Outcomes (1)

• DNA fragmentation by Comet assay

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

  1 months

Secondary Outcomes (8)

• Sperm count

  1 months

• Forward motility

  1 months

• Sperm velocities measured by CASA

  1 months

• Morphology

  1 months

• Sperm aneuploidy

  1 months

Study Arms (2)

Microfluidic Chip Method

EXPERIMENTAL

The Sperm Separation Device - ZyMōt Multi 850µL device (ZyMōt Fertility, Inc) will be used. The microfluidic chamber will be used based on the manufacturer's instructions. 850 μL of the semen sample will be added to the inlet port of the device and 750 μL of fertilization media will be added to the outlet port. The device will then be incubated in 6% CO2 at 37°C. After 30 minutes, 500 μL of the prepared sample at the outlet port will be removed and pipetted into a labelled test tube. The final volume will be adjusted to 1mL for sperm counting.

Device: ZyMōt Multi 850µL device

Density Gradient Centrifugation Method

ACTIVE COMPARATOR

After liquefaction, sperm preparation will be completed by a discontinuous density gradient centrifugation method, using Pureception (CooperSurgical, Denmark) sperm density gradient media. The resulting sperm pellet after centrifugation will be washed once with the sperm washing medium (G-IVF Plus, Vitrolife, Sweden) The washed spermatozoa will be resuspended with the same medium, adjusting the final volume to 500 μL. The final volume will be adjusted to 1mL for sperm counting.

Device: Density Gradient Centrifugation Method

Interventions

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.

Microfluidic Chip Method

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).

Density Gradient Centrifugation Method

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Professor Ernest Hung-Yu Ng: lead

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

YU WING TONG, MBBS

CONTACT

92707722; ptong@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the laboratory staff in the IVF laboratory performing sperm preparation will be aware of the group assignment. Another laboratory staff who is not involved in performing sperm preparation and is not aware of the group assignment will perform the semen analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This randomized controlled trial aims compare the effect of sperm preparation by a microfluidic chip method versus a density gradient centrifugation method on semen parameters prior to the start of a randomized trial comparing the effects of the two sperm preparation methods on the cumulative live birth rates of in vitro fertilization.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: August 7, 2023
• Study Start: July 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)