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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
119
Sperm selection using the ZyMot Microfluidic Sperm Separation Device. Process involves loading semen into microfluidic channels to isolate motile sperm with low DNA fragmentation.
Sperm preparation using a discontinuous density gradient technique with SpermGrad and SpermRinse media. Centrifugation separates motile sperm for use in ICSI.
Center of IVF and Tissue Engineering, Hanoi Medical University Hospital
Hà Nội, Vietnam
Sperm DNA Fragmentation Index (DFI)
DFI measured before and after sperm preparation using SCSA method. Comparison between microfluidics and DGC groups
Time frame: Day of oocyte retrieval
Live birth rate
Defined as the delivery of a live-born infant after 22 weeks of gestation. Comparison between microfluidics and DGC groups.
Time frame: Up to 9 months after embryo transfer
Sperm motility after preparation
Percentage of motile sperm, including both progressive and non-progressive motility, assessed post-preparation using WHO 2021 criteria.
Time frame: Immediately after sperm preparation
Normal sperm morphology
Percentage of sperm with normal morphology after preparation, assessed using strict WHO 2021 criteria.
Time frame: Immediately after sperm preparation
Fertilization rate
Proportion of injected oocytes showing two pronuclei (2PN).
Time frame: 17-20 hours after ICSI
Good-quality embryo rate on Day 2
Percentage of embryos with 4-6 blastomeres and \<10% fragmentation on Day 2.
Time frame: Day 2 after fertilization
Biochemical pregnancy rate
Defined as serum β-hCG \>25 IU/L after embryo transfer.
Time frame: 10-12 days after embryo transfer
Clinical pregnancy rate
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Presence of gestational sac and fetal heartbeat confirmed on ultrasound.
Time frame: 4 weeks after embryo transfer
Ongoing pregnancy rate
Viable intrauterine pregnancy confirmed by ultrasound at 12 weeks.
Time frame: 12 weeks after embryo transfer