NCT07605182

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
378

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2027

Study Start

First participant enrolled

May 5, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 10, 2026

Last Update Submit

May 19, 2026

Conditions

Male InfertilityAdvanced Paternal AgeAssisted Reproductive Technology

Keywords

DNA fragmentationAdvanced paternal ageICSILensHooke CA0

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    Immediately after sperm preparation on the day of oocyte retrieval

  • Blastocyst rate and good-quality blastocysts rate

    Day 5 to Day 6 after ICSI

  • Euploidy rate.

    Within 2 weeks after blastocyst biopsy

Study Arms (2)

Study group (CA0)

EXPERIMENTAL

Sperm preparation using LensHooke® CA0 live motile sperm sorting device.

Device: LensHooke® CA0 sperm sorting device

Control group (DGC)

ACTIVE COMPARATOR

Conventional sperm preparation using density gradient centrifugation.

Device: Density Gradient Centrifugation

Interventions

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.

Study group (CA0)
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.

Control group (DGC)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vietnam Military medical university

Hà Nội, Ha Dong, 100000, Vietnam

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

UltracentrifugationCentrifugationInvestigative TechniquesChemistry Techniques, Analytical

Central Study Contacts

Son The Trinh

CONTACT

+ 84 902150873trinhtheson@vmmu.edu.vn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PhD., Associate Prof

Study Record Dates

First Submitted

May 10, 2026

First Posted

May 22, 2026

Study Start

May 5, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

VN(1)