ClinicalTrials.gg
CompletedNCT05866484TESA vs ZymotUpdated Jul 12, 2024

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

An observational study in Infertility, Male, Azoospermia and Reproductive Disorder, sponsored by Clinique Ovo. Completed at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.

Primary conditionAzoospermiaRegistry: Infertility, MaleReclassifiedWhy we changed it
Registry
Infertility, Male — the first condition term the registry derived for this study.
ClinicalTrials.gg
Azoospermia
Why
  1. The study's listed conditions name Azoospermia, a narrower term within Infertility, Male.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Clinique Ovo · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
280
Ages
18 Years and older
Sex
Male
01

Study 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

02

Conditions studied

  • Infertility, Male
  • Azoospermia
  • Reproductive Disorder

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03

In context

Azoospermia Reclassified

59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.

This study's enrollment of 280 is above the median of 95 across 24 observational studies indexed under Azoospermia.

Browse Azoospermia studies →

Lead sponsor

Clinique Ovo is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Compared within Azoospermia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infertility, Male. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men with high DNA fragmentation (>20%) undergoing TESA-ICSI or Zymot-ICSI

Exclusion criteria

Exclusion Criteria:

  • Spouse with advanced maternal age (> 40 years)
  • Egg donation cycle
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
280 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

06

What researchers measure

Primary outcomes

  1. Clinical Pregnancy Rate

    Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation

    Time frame: approximately 8 weeks

Secondary outcomes

  1. Number of utilizable blastocysts obtained

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

    Time frame: Approximately 20 days

07

Study locations

1 site
  • Clinique Ovo
    Montreal, Quebec H4P 2S4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05866484
Lead sponsor
Clinique Ovo
Responsible party
Sponsor
First posted
May 19, 2023
Start date
May 10, 2023
Primary completion
Mar 30, 2024
Completion
May 31, 2024
Last update
Jul 12, 2024

Study contacts

Armand Zini, MD
principal investigator · Clinique Ovo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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