Microfluidics Versus Density Gradient Centrifugation for Sperm Preparation in IVF (MCvsDGC)

Hanoi Medical University

Status: Completed

Conditions: In Vitro Fertilization (IVF); Sperm DNA Fragmentation; Male Infertility

Treatments: Procedure: Microfluidic sperm sorting; Procedure: Density Gradient Centrifugation

Study type: Interventional

Funder types: Other

Identifiers

NCT07004309

HU-MCvsDGC-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female partner aged between 18 and 40 years
• Couples undergoing in vitro fertilization (IVF) cycles at the IVF and Tissue Engineering Center, Hanoi Medical University, between January 2022 and January 2024
• Use of autologous oocytes
• Use of ejaculated sperm
• Both partners provide written informed consent

Exclusion criteria

• Use of donor oocytes or donor sperm

• Requirement for testicular sperm extraction

• Diagnosis of oligoasthenozoospermia (OA) based on WHO 2021 criteria

• Female partner classified as having poor ovarian prognosis according to the POSEIDON 2016 criteria, including:

  • Anti-Müllerian hormone (AMH) level < 1.2 ng/mL
  • Antral follicle count (AFC) < 5
  • Or history of poor ovarian response (≤9 oocytes retrieved in previous cycles)

• Preimplantation genetic testing (PGT) cycles

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 2 patient groups

Microfluidics Group

Experimental group

Description:

Semen samples are processed using a microfluidic sperm sorting device (ZyMot). Selected sperm are used for ICSI.

Treatment:

Procedure: Microfluidic sperm sorting

DGC Group

Active Comparator group

Description:

Sperm preparation using a discontinuous density gradient method with SpermGrad and SpermRinse media.

Treatment:

Procedure: Density Gradient Centrifugation