Comparative Efficacy of Microfluidics and Density Gradient Centrifugation for Sperm Preparation in IVF: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Sperm DNA Fragmentation Index (DFI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Embryologists performing ICSI and embryo evaluation were blinded to the group assignment.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Sperm DNA Fragmentation Index (DFI)
时间窗: Day of oocyte retrieval
DFI measured before and after sperm preparation using SCSA method. Comparison between microfluidics and DGC groups
Live birth rate
时间窗: 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.
次要结局
- Sperm motility after preparation(Immediately after sperm preparation)
- Normal sperm morphology(Immediately after sperm preparation)
- Fertilization rate(17-20 hours after ICSI)
- Good-quality embryo rate on Day 2(Day 2 after fertilization)
- Biochemical pregnancy rate(10-12 days after embryo transfer)
- Clinical pregnancy rate(4 weeks after embryo transfer)
- Ongoing pregnancy rate(12 weeks after embryo transfer)
研究者
Do Thuy Huong
MD, PhD candidate
Hanoi Medical University