Evaluation of the Effectiveness of Live Motile Sperm Sorting Device on In Vitro Fertilization Outcomes in Advanced Paternal Age Group
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 378
- 试验地点
- 2
研究概览
简要总结
Male infertility contributes significantly to infertility, particularly in advanced paternal age men where sperm DNA fragmentation is increased. Conventional density gradient centrifugation may induce oxidative stress and sperm damage. LensHooke® CA0 is a centrifugation-free sperm sorting device designed to improve sperm quality and reduce DNA fragmentation. This prospective comparative study evaluates the effectiveness of CA0 versus conventional density gradient centrifugation on post-processing sperm quality, DNA fragmentation index, blastocyst formation, euploid embryo rate, and clinical pregnancy outcomes in IVF/ICSI cycles involving men aged 40 years or older
详细描述
Male infertility contributes to approximately 50% of all infertility cases. One of the essential steps in assisted reproductive technology (ART) is sperm preparation, which aims to select motile, morphologically normal spermatozoa with minimal DNA damage. However, conventional sperm preparation techniques involving centrifugation may increase oxidative stress and sperm DNA fragmentation. The live motile sperm sorting device LensHooke® CA0 has been proposed as an alternative to traditional density gradient centrifugation (DGC), aiming to reduce sperm damage and potentially improve IVF outcomes.
LensHooke® CA0 offers several advantages: it avoids centrifugation and the mechanical stress associated with it; optimally reduces the DNA fragmentation index (DFI); minimizes the risk of premature acrosome reaction (AR); is suitable for both normozoospermic and non-normozoospermic semen samples; simplifies workflow (only three pipetting steps required: loading, medium addition, and recovery); and ensures a high degree of standardization, reducing inter-technician variability.
Moreover, paternal age is an important factor influencing sperm quality and fertility potential. Studies have demonstrated that men over 40 years of age exhibit higher sperm DNA fragmentation rates, increased morphological and motility abnormalities, and are associated with a higher incidence of embryonic chromosomal abnormalities and reduced live birth rates. Therefore, this population particularly requires optimized sperm selection methods to improve IVF/ICSI outcomes.
This study aims to evaluate the clinical value of this device through two primary objectives:
- To compare sperm quality post-processing and the DNA fragmentation index between the CA0 method and the conventional DGC method in advanced paternal age group.
- To compare the rates of blastocyst formation, euploid embryos, and clinical pregnancy between the two sperm preparation techniques in advanced paternal age group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male partners aged ≥ 40 years
- •Semen analysis: volume ≥ 1.4 mL, sperm concentration ≥ 6 million/mL, progressive motility (PR) ≥ 20% after 3-5 days of abstinence.
- •Female partners with ≥ 5 mature (MII) oocytes retrieved.
- •Couples undergoing ICSI with PGT-A and elective single embryo transfer (eSET).
- •Willingness to participate and sign informed consent.
排除标准
- •Azoospermia, surgical sperm retrieval, or use of cryopreserved sperm.
- •Female uterine or ovarian conditions severely affecting IVF outcomes.
- •Use of donor sperm or donor oocytes
研究组 & 干预措施
Study group (CA0)
Sperm preparation using LensHooke® CA0 live motile sperm sorting device.
干预措施: LensHooke® CA0 sperm sorting device (Device)
Control group (DGC)
Conventional sperm preparation using density gradient centrifugation.
干预措施: Density Gradient Centrifugation (Device)
研究者
Trinh The Son
M.D., PhD., Associate Prof
Vietnam Military Medical University