Clinical trial NCT07004309: Microfluidics Versus Density Gradient Centrifugation for Sperm Preparation in IVF
Official title: Comparative Efficacy of Microfluidics and Density Gradient Centrifugation for Sperm Preparation in IVF: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Sperm DNA Fragmentation
In Vitro Fertilization (IVF)
Keywords: Microfluidics
Sperm DNA Fragmentation
In Vitro Fertilization
Sperm Preparation
ICSI
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized into two parallel arms: microfluidic sperm sorting vs. density gradient centrifugation, with equal allocation.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sperm DNA Fragmentation Index (DFI)
timeFrame: Day of oocyte retrieval
measure: Live birth rate
timeFrame: Up to 9 months after embryo transfer
Secondary outcomes:
measure: Sperm motility after preparation
timeFrame: Immediately after sperm preparation
measure: Normal sperm morphology
timeFrame: Immediately after sperm preparation
measure: Fertilization rate
timeFrame: 17-20 hours after ICSI
measure: Good-quality embryo rate on Day 2
timeFrame: Day 2 after fertilization
measure: Biochemical pregnancy rate
timeFrame: 10-12 days after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 4 weeks after embryo transfer
measure: Ongoing pregnancy rate
timeFrame: 12 weeks after embryo transfer
Other outcomes:
Locations:
city: Ha Noi
country: Vietnam
facility: Center of IVF and Tissue Engineering, Hanoi Medical University Hospital
Study officials:
affiliation: Hanoi Medical University
name: Do Thuy Huong, PhD candidate
role: PRINCIPAL_INVESTIGATOR
References: