NCT07004309

Microfluidics Versus Density Gradient Centrifugation for Sperm Preparation in IVF

Comparative Efficacy of Microfluidics and Density Gradient Centrifugation for Sperm Preparation in IVF: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Hanoi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aimed to compare the effectiveness of microfluidic sperm sorting and density gradient centrifugation (DGC) in reducing sperm DNA fragmentation index (DFI) and improving clinical outcomes in IVF. A total of 119 couples underwent IVF and were assigned to either microfluidic or DGC sperm preparation. The study evaluated sperm quality, fertilization, embryo development, and live birth rates.

Detailed description

This single-center randomized controlled trial was conducted at Hanoi Medical University Hospital from March 2023 to March 2024. Couples undergoing IVF were randomized to two sperm preparation methods: microfluidics or density gradient centrifugation. Sperm DNA fragmentation index (DFI) was assessed before and after preparation. Primary outcomes included live birth rate and DFI reduction; secondary outcomes included sperm motility and morphology, fertilization rate, embryo quality, and pregnancy outcomes. The study received IRB approval and adhered to ethical standards.

Conditions

• Male Infertility
• Sperm DNA Fragmentation
• In Vitro Fertilization (IVF)

Interventions

Type	Name	Description
PROCEDURE	Microfluidic sperm sorting	Sperm selection using the ZyMot Microfluidic Sperm Separation Device. Process involves loading semen into microfluidic channels to isolate motile sperm with low DNA fragmentation.
PROCEDURE	Density Gradient Centrifugation	Sperm preparation using a discontinuous density gradient technique with SpermGrad and SpermRinse media. Centrifugation separates motile sperm for use in ICSI.

Timeline

• Start date: 2023-03-14
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2025-06-04
• Last updated: 2025-06-05

Locations

1 site across 1 country: Vietnam