Male InfertilityIVFNCT07605182
Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age
A study testing LensHooke® CA0 sperm sorting device and Density Gradient Centrifugation in people with Male Infertility and Advanced Paternal Age, run by Vietnam Military Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Male Infertility, Advanced Paternal Age, Assisted Reproductive Technology
- What is being tested?
- LensHooke® CA0 sperm sorting device and Density Gradient Centrifugation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jul 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Vietnam Military medical university
Hà Nội, Ha Dong, 100000
Phuong Minh Nguyen, M.D, 0963048428, nguyenminhphuongk53@vmmu.edu.vn
About this study
Official title: 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
Read the 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:
- 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.
- Being tested
- LensHooke® CA0 sperm sorting device, Density Gradient Centrifugation
- Keywords
- DNA fragmentation, Advanced paternal age, ICSI, LensHooke CA0
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LensHooke® CA0 sperm sorting deviceDevice
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 CentrifugationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group (CA0) | Experimental | Sperm preparation using LensHooke® CA0 live motile sperm sorting device. Receives: Device: LensHooke® CA0 sperm sorting device |
| Control group (DGC) | Active comparator | Conventional sperm preparation using density gradient centrifugation. Receives: Device: Density Gradient Centrifugation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate after single embryo transfer
Confirmed by the presence of an intrauterine gestational sac on ultrasound.
Measured: 4 to 6 weeks after embryo transfer
Secondary outcomes (3)
Post-processing sperm DNA fragmentation index (DFI, %)
Evaluated using the LensHooke® R11 Plus assay
Measured: 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)
Measured: Day 5 to Day 6 after ICSI
Euploidy rate.
Assessed via preimplantation genetic testing for aneuploidy (PGT-A) using next-generation sequencing (NGS).
Measured: Within 2 weeks after blastocyst biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vietnam Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Vinmec Healthcare System, Andrology and Fertility Hospital of Hanoi
- Responsible party
- Principal investigator, Trinh The Son, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605182
- Sponsor's protocol ID
- MICEH-2026-01
- Acronym
- IVF
- Status last verified
- Aug 2026
- First submitted
- 10 May 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Live Motile Sperm Sorting Device on In Vitro Fertilization Outcomes in Advanced Paternal Age Group
- ClinicalTrials.gov ID
- NCT07605182
- Acronym / sponsor ID
- IVF / MICEH-2026-01
- Keywords
- DNA fragmentation, Advanced paternal age, ICSI, LensHooke CA0
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Vietnam Military Medical UniversityUniversity, hospital or other
- Collaborators
- 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, Vinmec Healthcare System, Andrology and Fertility Hospital of Hanoi
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (CA0) | Experimental | Device: LensHooke® CA0 sperm sorting deviceSperm preparation using LensHooke® CA0 live motile sperm sorting device. |
| Control group (DGC) | Active comparator | Device: Density Gradient CentrifugationConventional sperm preparation using density gradient centrifugation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LensHooke® CA0 sperm sorting deviceSperm 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 | Study group (CA0) |
| Density Gradient CentrifugationSperm 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. | Device | Control group (DGC) |
Primary outcome
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.
3 secondary outcomes
Post-processing sperm DNA fragmentation index (DFI, %)
Time frame: Immediately after sperm preparation on the day of oocyte retrieval
Blastocyst rate and good-quality blastocysts rate
Time frame: Day 5 to Day 6 after ICSI
Euploidy rate.
Time frame: Within 2 weeks after blastocyst biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LensHooke® CA0 sperm sorting device and Density Gradient Centrifugation in people with Male Infertility and Advanced Paternal Age, run by Vietnam Military Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Son The Trinh (+ 84 902150873, trinhtheson@vmmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate after single embryo transfer (time frame: 4 to 6 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.