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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Male Infertility; Assisted Reproductive Technology; Advanced Paternal Age
• Intervention / Treatment: Device: LensHooke® CA0 sperm sorting device; Device: Density Gradient Centrifugation

Detailed Description

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:

1. 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.
2. To compare the rates of blastocyst formation, euploid embryos, and clinical pregnancy between the two sperm preparation techniques in advanced paternal age group.

• Study Type: Interventional
• Enrollment (Estimated): 378
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Son The Trinh; Phone Number: + 84 902150873; Email: trinhtheson@vmmu.edu.vn

Study Locations

• Vietnam
  • Ha Dong
    • Hà Nội, Ha Dong, Vietnam, 100000
      • Vietnam Military Medical University
      • Contact: Phuong Minh Nguyen, M.D; Phone Number: 0963048428; Email: nguyenminhphuongk53@vmmu.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group (CA0); Sperm preparation using LensHooke® CA0 live motile sperm sorting device.	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.
Active Comparator: Control group (DGC); Conventional sperm preparation using density gradient centrifugation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate after single embryo transfer	Confirmed by the presence of an intrauterine gestational sac on ultrasound.	4 to 6 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-processing sperm DNA fragmentation index (DFI, %)	Evaluated using the LensHooke® R11 Plus assay	Immediately after sperm preparation on the day of oocyte retrieval
Blastocyst rate and good-quality blastocysts rate	Evaluated according to Gardner's criteria and classified following Munné et al. (2019)	Day 5 to Day 6 after ICSI
Euploidy rate.	Assessed via preimplantation genetic testing for aneuploidy (PGT-A) using next-generation sequencing (NGS).	Within 2 weeks after blastocyst biopsy

Collaborators and Investigators

• Sponsor: Vietnam Military Medical University
• Collaborators: Andrology and Fertility Hospital of Hanoi; Vinmec Healthcare System; National Hospital of Obstetrics and Gynecology; Tam Anh TP. Ho Chi Minh General Hospital; Viet-Belgium Andrology and Infertility Hospital; Phuong Chau International Hospital; Dong Do Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 5, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: May 10, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ICSI; DNA fragmentation; Advanced paternal age; LensHooke CA0
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility; Infertility, Male; Investigative Techniques; Chemistry Techniques, Analytical; Ultracentrifugation; Centrifugation; Centrifugation, Density Gradient
• Other Study ID Numbers: MICEH-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No