Health Trials

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

ConditionsMale InfertilityAdvanced Paternal AgeAssisted Reproductive Technology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorVietnam Military Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

378 Participants
are divided into 2 treatment groups
Group A: Study group (CA0)Experimental treatment 1 intervention
Group B: Control group (DGC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Pregnancy Rate after single embryo transfer

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

Time frame
4 to 6 weeks after embryo transfer

Secondary outcomes

1

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

Evaluated using the LensHooke® R11 Plus assay

Time frame
Immediately after sperm preparation on the day of oocyte retrieval
2

Blastocyst rate and good-quality blastocysts rate

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

Time frame
Day 5 to Day 6 after ICSI
3

Euploidy rate.

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

Time frame
Within 2 weeks after blastocyst biopsy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vietnam Military Medical University

Lead sponsor

National Hospital of Obstetrics and Gynecology

Collaborator

Tam Anh TP. Ho Chi Minh General Hospital

Collaborator

Viet-Belgium Andrology and Infertility Hospital

Collaborator

Phuong Chau International Hospital

Collaborator

Dong Do Hospital

Collaborator

Vinmec Healthcare System

Collaborator

Andrology and Fertility Hospital of Hanoi

Collaborator

Source ClinicalTrials.gov
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