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

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

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

Study Overview

• Status: Completed
• Conditions: Infertility, Male; Azoospermia; Reproductive Disorder

• Study Type: Observational
• Enrollment (Actual): 280

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4P 2S4
      • Clinique ovo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate	Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation	approximately 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of utilizable blastocysts obtained	Compare the number of utilizable embryos obtained in couples using TESA-ICSI vs Zymot-ICSI	Approximately 20 days

Collaborators and Investigators

• Sponsor: Clinique Ovo
• Investigators: Principal Investigator: Armand Zini, MD, Clinique ovo

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Infertility; Infertility, Male; Azoospermia
• Other Study ID Numbers: 3277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No