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NCT Number: NCT07605182

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vietnam Military medical university

Hà Nội, Ha Dong, 100000, Vietnam

Location contact

Phuong Minh Nguyen, M.D

CONTACT

[email protected]

0963048428

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LensHooke® CA0 sperm sorting device

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.

Density gradient centrifugation

Device

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.

Primary outcomes

  1. Clinical Pregnancy Rate after single embryo transfer

    Time frame: 4 to 6 weeks after embryo transfer

    Confirmed by the presence of an intrauterine gestational sac on ultrasound.

Secondary outcomes

  1. Post-processing sperm DNA fragmentation index (DFI, %)

    Time frame: Immediately after sperm preparation on the day of oocyte retrieval

    Evaluated using the LensHooke® R11 Plus assay

  2. Blastocyst rate and good-quality blastocysts rate

    Time frame: Day 5 to Day 6 after ICSI

    Evaluated according to Gardner's criteria and classified following Munné et al. (2019)

  3. Euploidy rate.

    Time frame: Within 2 weeks after blastocyst biopsy

    Assessed via preimplantation genetic testing for aneuploidy (PGT-A) using next-generation sequencing (NGS).

Study contacts

Contact information is provided by the study sponsor or research team.

Son The Trinh

CONTACT

[email protected]

+ 84 902150873

Sponsors and collaborators

Lead sponsor

Vietnam Military Medical University

Other

Collaborators

  • Andrology and Fertility Hospital of Hanoi
  • Dong Do Hospital
  • National Hospital of Obstetrics and Gynecology
  • Phuong Chau International Hospital
  • Tam Anh TP. Ho Chi Minh General Hospital
  • Viet-Belgium Andrology and Infertility Hospital
  • Vinmec Healthcare System

Registry information

Official study title

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

Acronym: IVF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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