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

Ovo Clinic

Status: Completed

Conditions: Azoospermia; Reproductive Disorder; Infertility, Male

Study type: Observational

Funder types: Industry

Identifiers

NCT05866484

3277

Details and patient eligibility

About

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

Enrollment: 280 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

280 participants in 2 patient groups

TESA-ICSI

Description:

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

Zymot-ICSI

Description:

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