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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microfluidics Group | Experimental | Semen samples are processed using a microfluidic sperm sorting device (ZyMot). Selected sperm are used for ICSI. |
|
| DGC Group | Active Comparator | Sperm preparation using a discontinuous density gradient method with SpermGrad and SpermRinse media. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm DNA Fragmentation Index (DFI) | DFI measured before and after sperm preparation using SCSA method. Comparison between microfluidics and DGC groups | 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. | Up to 9 months after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm motility after preparation | Percentage of motile sperm, including both progressive and non-progressive motility, assessed post-preparation using WHO 2021 criteria. | Immediately after sperm preparation |
| Normal sperm morphology |
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Inclusion Criteria:
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:
Preimplantation genetic testing (PGT) cycles
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| Name | Affiliation | Role |
|---|---|---|
| Do Thuy Huong, PhD candidate | Hanoi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of IVF and Tissue Engineering, Hanoi Medical University Hospital | Hà Nội | 100000 | Vietnam |
Individual participant data (IPD) will not be shared due to the sensitive nature of infertility treatment and to protect patient privacy in compliance with institutional ethics guidelines.
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D002499 | Centrifugation, Density Gradient |
| ID | Term |
|---|---|
| D014461 | Ultracentrifugation |
| D002498 | Centrifugation |
| D008919 | Investigative Techniques |
| D002623 | Chemistry Techniques, Analytical |
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Participants were randomized into two parallel arms: microfluidic sperm sorting vs. density gradient centrifugation, with equal allocation.
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Embryologists performing ICSI and embryo evaluation were blinded to the group assignment.
| 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. |
|
Percentage of sperm with normal morphology after preparation, assessed using strict WHO 2021 criteria.
| Immediately after sperm preparation |
| Fertilization rate | Proportion of injected oocytes showing two pronuclei (2PN). | 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. | Day 2 after fertilization |
| Biochemical pregnancy rate | Defined as serum β-hCG >25 IU/L after embryo transfer. | 10-12 days after embryo transfer |
| Clinical pregnancy rate | Presence of gestational sac and fetal heartbeat confirmed on ultrasound. | 4 weeks after embryo transfer |
| Ongoing pregnancy rate | Viable intrauterine pregnancy confirmed by ultrasound at 12 weeks. | 12 weeks after embryo transfer |
| D052801 |
| Male Urogenital Diseases |