In Vitro Fertilization (IVF), Male Infertility, Sperm DNA Fragmentation
Conditions
Keywords
Microfluidics, Sperm DNA Fragmentation, In Vitro Fertilization, Sperm Preparation, ICSI
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREMicrofluidic 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.
PROCEDUREDensity Gradient Centrifugation
Sperm preparation using a discontinuous density gradient technique with SpermGrad and SpermRinse media. Centrifugation separates motile sperm for use in ICSI.
Sponsors
Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Embryologists performing ICSI and embryo evaluation were blinded to the group assignment.
Intervention model description
Participants were randomized into two parallel arms: microfluidic sperm sorting vs. density gradient centrifugation, with equal allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm DNA Fragmentation Index (DFI) | Day of oocyte retrieval | DFI measured before and after sperm preparation using SCSA method. Comparison between microfluidics and DGC groups |
| Live birth rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Fertilization rate | 17-20 hours after ICSI | Proportion of injected oocytes showing two pronuclei (2PN). |
| Good-quality embryo rate on Day 2 | Day 2 after fertilization | Percentage of embryos with 4-6 blastomeres and \<10% fragmentation on Day 2. |
| Sperm motility after preparation | Immediately after sperm preparation | Percentage of motile sperm, including both progressive and non-progressive motility, assessed post-preparation using WHO 2021 criteria. |
| Clinical pregnancy rate | 4 weeks after embryo transfer | Presence of gestational sac and fetal heartbeat confirmed on ultrasound. |
| Ongoing pregnancy rate | 12 weeks after embryo transfer | Viable intrauterine pregnancy confirmed by ultrasound at 12 weeks. |
| Biochemical pregnancy rate | 10-12 days after embryo transfer | Defined as serum β-hCG \>25 IU/L after embryo transfer. |
| Normal sperm morphology | Immediately after sperm preparation | Percentage of sperm with normal morphology after preparation, assessed using strict WHO 2021 criteria. |
Countries
Vietnam
Outcome results
None listed