Microfluidics Versus Density Gradient Centrifugation for Sperm Preparation in IVF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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

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Male Infertility Sperm DNA Fragmentation In Vitro Fertilization (IVF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomized into two parallel arms: microfluidic sperm sorting vs. density gradient centrifugation, with equal allocation.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Embryologists performing ICSI and embryo evaluation were blinded to the group assignment.

Study Groups

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Microfluidics Group

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

Group Type EXPERIMENTAL

Microfluidic sperm sorting

Intervention Type PROCEDURE

Sperm selection using the ZyMot Microfluidic Sperm Separation Device. Process involves loading semen into microfluidic channels to isolate motile sperm with low DNA fragmentation.

DGC Group

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

Group Type ACTIVE_COMPARATOR

Density Gradient Centrifugation

Intervention Type PROCEDURE

Sperm preparation using a discontinuous density gradient technique with SpermGrad and SpermRinse media. Centrifugation separates motile sperm for use in ICSI.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No