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

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

Conditions

• Male Infertility
• Advanced Paternal Age
• Assisted Reproductive Technology

Interventions

DEVICE

LensHooke® 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.

DEVICE

Density 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.

Sponsors & Collaborators

• National Hospital of Obstetrics and Gynecology

  collaborator OTHER

• Tam Anh TP. Ho Chi Minh General Hospital

  collaborator OTHER

• Viet-Belgium Andrology and Infertility Hospital

  collaborator UNKNOWN

• Phuong Chau International Hospital

  collaborator UNKNOWN

• Dong Do Hospital

  collaborator UNKNOWN

• Vinmec Healthcare System

  collaborator OTHER

• Andrology and Fertility Hospital of Hanoi

  collaborator OTHER

• Vietnam Military Medical University

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-05

Primary Completion

2027-04-30

Completion

2027-12-30

Countries

• Vietnam

Study Locations