RecruitingNot ApplicableNCT07605182

Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age

Evaluation of the Effectiveness of Live Motile Sperm Sorting Device on In Vitro Fertilization Outcomes in Advanced Paternal Age Group

Sponsor

Vietnam Military Medical University

Enrollment

378 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

Male infertility Advanced Paternal Age assisted reproductive technology

Summary

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

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Density Gradient Centrifugation and LensHooke® CA0 sperm sorting device for people with advanced paternal age, male infertility, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELensHooke® CA0 sperm sorting device

Sperm will be processed using the CA0 device by loading 1.0 mL of semen into the lower chamber and adding 0.9 mL of pre-equilibrated sperm washing medium into the upper chamber. The device is incubated at 37 °C for a minimum of 30 minutes, followed by aspirating 0.5 mL of recovered sperm suspension for ICSI.

DEVICEDensity Gradient Centrifugation

Sperm will be prepared by layering 1 mL of 45% medium and 1 mL of 90% medium with 1 mL of semen sample. This is followed by a first centrifugation at 1500 rpm for 15 minutes, a wash step using 2 mL G-IVF plus medium, and a second centrifugation at 1200 rpm for 10 minutes to retain 0.5 mL of the sperm suspension.