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NCT Number: NCT07004309

Microfluidics Versus Density Gradient Centrifugation for Sperm Preparation in IVF

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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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male In Vitro Fertilization (IVF) Infertility Infertility, Male Male Urogenital Diseases Sperm DNA Fragmentation Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of IVF and Tissue Engineering, Hanoi Medical University Hospital

Hà Nội, 100000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microfluidic sperm sorting

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.

Density Gradient Centrifugation

Procedure

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

Primary outcomes

  1. Sperm DNA Fragmentation Index (DFI)

    Time frame: Day of oocyte retrieval

    DFI measured before and after sperm preparation using SCSA method. Comparison between microfluidics and DGC groups

  2. Live birth rate

    Time frame: Up to 9 months after embryo transfer

    Defined as the delivery of a live-born infant after 22 weeks of gestation. Comparison between microfluidics and DGC groups.

Secondary outcomes

  1. Sperm motility after preparation

    Time frame: Immediately after sperm preparation

    Percentage of motile sperm, including both progressive and non-progressive motility, assessed post-preparation using WHO 2021 criteria.

  2. Normal sperm morphology

    Time frame: Immediately after sperm preparation

    Percentage of sperm with normal morphology after preparation, assessed using strict WHO 2021 criteria.

  3. Fertilization rate

    Time frame: 17-20 hours after ICSI

    Proportion of injected oocytes showing two pronuclei (2PN).

  4. Good-quality embryo rate on Day 2

    Time frame: Day 2 after fertilization

    Percentage of embryos with 4-6 blastomeres and <10% fragmentation on Day 2.

  5. Biochemical pregnancy rate

    Time frame: 10-12 days after embryo transfer

    Defined as serum β-hCG >25 IU/L after embryo transfer.

  6. Clinical pregnancy rate

    Time frame: 4 weeks after embryo transfer

    Presence of gestational sac and fetal heartbeat confirmed on ultrasound.

  7. Ongoing pregnancy rate

    Time frame: 12 weeks after embryo transfer

    Viable intrauterine pregnancy confirmed by ultrasound at 12 weeks.

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Official study title

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

Acronym: MCvsDGC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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