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

NCT ID: NCT05866484

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-05-31

Brief Summary

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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

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Conditions

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Infertility, Male Azoospermia Reproductive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TESA-ICSI

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

No interventions assigned to this group

Zymot-ICSI

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Clinique Ovo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armand Zini, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

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Clinique Ovo

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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3277

Identifier Type: -

Identifier Source: org_study_id

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