Infertility, MaleTESA vs ZymotNCT05866484
Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS)
An observational study of Infertility, Male and Azoospermia, run by Clinique Ovo at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infertility, Male, Azoospermia, Reproductive Disorder
- How many people
- 280 participants
- Where
- 1 siteCanada
- Study dates
- 10 May 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Men with high DNA fragmentation (>20%) undergoing TESA-ICSI or Zymot-ICSI
Who cannot join
- Spouse with advanced maternal age (> 40 years)
- Egg donation cycle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS) in Couples With High Sperm DNA Fragmentation Undergoing ICSI: Which Approach is Better
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
- Conditions
- Infertility, Male, Azoospermia, Reproductive Disorder
- Medical subject headings
- Infertility, Male, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation
Measured: 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
Measured: Approximately 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start10 May 2023
- Primary completion30 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Armand Zini, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866484
- Sponsor's protocol ID
- 3277
- Acronym
- TESA vs Zymot
- Status last verified
- Jul 2024
- First submitted
- 10 May 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS) in Couples With High Sperm DNA Fragmentation Undergoing ICSI: Which Approach is Better
- ClinicalTrials.gov ID
- NCT05866484
- Acronym / sponsor ID
- TESA vs Zymot / 3277
- Conditions
- Infertility, Male, Azoospermia, Reproductive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Men with high DNA fragmentation (>20%) undergoing TESA-ICSI or Zymot-ICSI
Key exclusion criteria (2 listed)
- Spouse with advanced maternal age (> 40 years)
- Egg donation cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Pregnancy Rate
Time frame: approximately 8 weeks
Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation
1 secondary outcome
Number of utilizable blastocysts obtained
Time frame: Approximately 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armand Zini, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Male and Azoospermia, run by Clinique Ovo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.