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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Viet Nam
Vietnam Military medical university
RECRUITING
Hà Nội
Contact Information
Primary
Son The Trinh
trinhtheson@vmmu.edu.vn
+ 84 902150873
Time Frame
Start Date: 2026-07-15
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 378
Treatments
Experimental: Study group (CA0)
Sperm preparation using LensHooke® CA0 live motile sperm sorting device.
Active_comparator: Control group (DGC)
Conventional sperm preparation using density gradient centrifugation.
Related Therapeutic Areas
Sponsors
Leads: Vietnam Military Medical University
Collaborators: Phuong Chau International Hospital, Dong Do Hospital, Vinmec Healthcare System, Viet-Belgium Andrology and Infertility Hospital, National Hospital of Obstetrics and Gynecology, Andrology and Fertility Hospital of Hanoi, Tam Anh TP. Ho Chi Minh General Hospital

This content was sourced from clinicaltrials.gov

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