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OpenTrials
Completed

NCT Number: NCT05866484

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

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical Pregnancy Rate

    Time frame: approximately 8 weeks

    Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation

Secondary outcomes

  1. Number of utilizable blastocysts obtained

    Time frame: Approximately 20 days

    Compare the number of utilizable embryos obtained in couples using TESA-ICSI vs Zymot-ICSI

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Registry information

Official study title

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

Acronym: TESA vs Zymot

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 19, 2023
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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