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NCT05866484 Clinical Trial

Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS)

Infertility, Male Clinical Trial

— TESA vs Zymot  

Official title:
Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS) in Couples With High Sperm DNA Fragmentation Undergoing ICSI: Which Approach is Better

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05866484
Other study ID # 3277
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 10, 2023
Est. completion date May 31, 2024

Study information
Verified date October 2023
Source Clinique Ovo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Normal embryonic development relies on the correct transmission of genetic information, and sperm DNA plays a crucial part in this process. Causes of poor sperm DNA integrity include unhealthy lifestyles such as smoking and exposure to gonadotoxins, as well as, obesity, varicoceles, infections, advanced paternal age and systemic disorders. An increase in DNA fragmentation in sperm has been linked to lower fertilisation rate, poorer quality embryos, lower pregnancy rate, and high miscarriages rate. The best way for sperm selection and processing in assisted reproductive technologies (ART) should be noninvasive and cost-effective. It should also make it possible to identify high-quality spermatozoa and produce more favorable results in terms of pregnancy and live birth rates.7 Meanwhile, the microfluidic sperm separation technology is a less expensive and less invasive alternative. This method allows for the selection of motile sperm that have a normal morphology, low levels of reactive oxygen species (ROS), and low DFI

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 280
Est. completion date May 31, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Men with high DNA fragmentation (>20%) undergoing TESA-ICSI or Zymot-ICSI Exclusion Criteria: - Spouse with advanced maternal age (> 40 years) - Egg donation cycle

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Clinique Ovo Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Pregnancy Rate Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation approximately 8 weeks
Secondary Number of utilizable blastocysts obtained Compare the number of utilizable embryos obtained in couples using TESA-ICSI vs Zymot-ICSI Approximately 20 days
See also
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