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

Completed

• Conditions: Infertility, Male; Azoospermia; Reproductive Disorder

• Registration Number: NCT05866484
• Lead Sponsor: Clinique Ovo

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-19
• Primary Completion: 2024-03-30
• Study Completion: 2024-05-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 280

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	approximately 8 weeks	Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation

Secondary Outcome Measures

Name	Time	Method
Number of utilizable blastocysts obtained	Approximately 20 days	Compare the number of utilizable embryos obtained in couples using TESA-ICSI vs Zymot-ICSI

Trial Locations

Locations (1)

Clinique Ovo; 🇨🇦 Montreal, Quebec, Canada