Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- LensHooke® CA0 sperm sorting device
- Density Gradient Centrifugation
Treatment groups
378 Participants
are divided into 2 treatment groupsSponsors and collaborators
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