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

NCT05866484 | Completed

• 1 other identifier: 3277
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Infertility, Male; Azoospermia; Reproductive Disorder

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation

  approximately 8 weeks

Secondary Outcomes (1)

• Number of utilizable blastocysts obtained

  Approximately 20 days

Study Arms (2)

TESA-ICSI

Compare ICSI outcomes with high Sperm DNA fragmentation undergoing TESA (testicular sperm extraction)

Zymot-ICSI

Compare ICSI outcomes with high Sperm DNA fragmentation using microfluidic sperm separation device (Zymot)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study will compare and investigate ICSI outcomes in couples with high sperm DNA fragmentation using either testicular sperm (TESA) or microfluidic sperm separation device (Zymot)

You may qualify if:

• Men with high DNA fragmentation (\>20%) undergoing TESA-ICSI or Zymot-ICSI

You may not qualify if:

• Spouse with advanced maternal age (\> 40 years)
• Egg donation cycle

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility, Male; Azoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Armand Zini, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: May 10, 2023
• Primary Completion: March 30, 2024
• Study Completion: May 31, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)