Non Obstructive AzoospermiaNCT07286279
Identifying Candidates for Limited Dissection at Microdissection TESE.
An observational study of Non Obstructive Azoospermia and Cryptozoospermia, run by Clinique Ovo at 1 site in Canada.
Trial summary
The goal of this retrospective observational study is to learn whether certain clinical characteristics can help predict which infertile men may successfully have sperm retrieved using a less-invasive "mini-incision" version of micro-TESE. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Non Obstructive Azoospermia, Cryptozoospermia, Oligoasthenoteratozoospermia
- How many people
- 248 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2025to 15 Jan 2026
- 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: Men who underwent micro-TESE procedure from March 2015 to June 2025
Who may be able to join
- Patients with cryptozoospermia or non obstructive azoospermia that underwent a micro-TESE
Who cannot join
- Patients with a potentially reversible cause of cryptozoospermia (i.e., presence of a varicocele, febrile illness, or recent toxin exposure)
- Patients with suspected partial genital tract obstruction (i.e post-vaso-vasostomy, post-vasoepididymostomy, and low volume cryptozoospermia with ejaculatory duct obstruction)
- Patients who have previously undergone a micro-TESE, TESA or TESE procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Infertile Men Who May be Amenable to a Limited Testicular Dissection at Microdissection Testicular Sperm Extraction
The goal of this retrospective observational study is to learn whether certain clinical characteristics can help predict which infertile men may successfully have sperm retrieved using a less-invasive "mini-incision" version of micro-TESE. The study focuses on men with very low or absent sperm counts (non-obstructive azoospermia, cryptozoospermia, or severe OAT).
The main questions it aims to answer are:
Read more
Can sperm be successfully found using only a small, limited-dissection micro-TESE in some men?
Which clinical factors (such as hormone levels or medical history) help identify men who may benefit from this less-invasive approach?
Researchers will compare men who had successful sperm retrieval with the mini-incision alone to men who required a more extensive micro-TESE to see if certain characteristics predict which approach is likely to work.
Read the detailed description
This retrospective cohort study evaluates whether preoperative clinical characteristics can help identify infertile men who are likely to achieve successful sperm retrieval through a limited-dissection, mini-incision micro-TESE. The stepwise surgical approach begins with a small equatorial incision for targeted micro-biopsies and is expanded only when sperm are not initially identified.
The study includes men who underwent their first micro-TESE at a high-volume fertility center over a 10-year period. All procedures followed a standardized surgical protocol and were performed by a single experienced surgeon, ensuring uniformity in technique.
Clinical data routinely collected before surgery, such as hormone levels, semen parameters, testicular volume, and relevant medical history, were analyzed and compared between men who required only the mini-incision and those who proceeded to an extended dissection. By examining these differences, the study aims to determine whether certain patient characteristics can predict the success with the less-invasive approach.
The findings may help guide pre-surgical counseling and support more tailored surgical planning for men with severe male factor infertility
- Conditions
- Non Obstructive Azoospermia, Cryptozoospermia, Oligoasthenoteratozoospermia, Male Infertility
- Keywords
- micro-TESE, male infertility, non-obstructive azoospermia, cryptozoospermia, oligoasthenoteratozoospermia, mini-incision
- Medical subject headings
- Oligospermia, Infertility, Male
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful sperm retrieval rate defined as the presence of spermatozoa during limited dissection (mini-incision) micro-TESE
Measured: At the time of limited dissection (mini-incision)
Secondary outcomes (5)
Serum FSH levels
Measured: At baseline
Serum testosterone levels
Measured: At baseline
Testicular volume
Measured: At baseline
Genetic abnormalities rate
Measured: At baseline
Procedure conversion from limited to extensive micro-TESE rate
Measured: At the time of limited dissection (mini-incision)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start15 Dec 2025
- Primary completion31 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Obstructive AzoospermiaStudies 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286279
- Sponsor's protocol ID
- Mini incision Micro-TESE
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2025
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Infertile Men Who May be Amenable to a Limited Testicular Dissection at Microdissection Testicular Sperm Extraction
- ClinicalTrials.gov ID
- NCT07286279
- Acronym / sponsor ID
- Mini incision Micro-TESE
- Conditions
- Non Obstructive Azoospermia, Cryptozoospermia, Oligoasthenoteratozoospermia, Male Infertility
- Keywords
- micro-TESE, male infertility, non-obstructive azoospermia, cryptozoospermia, oligoasthenoteratozoospermia, mini-incision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 16 Dec 2025 (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.
The goal of this retrospective observational study is to learn whether certain clinical characteristics can help predict which infertile men may successfully have sperm retrieved using a less-invasive "mini-incision" version of micro-TESE. The study focuses on men with very low or absent sperm counts (non-obstructive azoospermia, cryptozoospermia, or severe OAT).
The main questions it aims to answer are:
Can sperm be successfully found using only a small, limited-dissection micro-TESE in some men?
Which clinical factors (such as hormone levels or medical history) help identify men who may benefit from this less-invasive approach?
Researchers will compare men who had successful sperm retrieval with the mini-incision alone to men who required a more extensive micro-TESE to see if certain characteristics predict which approach is likely to work.
Detailed description
This retrospective cohort study evaluates whether preoperative clinical characteristics can help identify infertile men who are likely to achieve successful sperm retrieval through a limited-dissection, mini-incision micro-TESE. The stepwise surgical approach begins with a small equatorial incision for targeted micro-biopsies and is expanded only when sperm are not initially identified.
The study includes men who underwent their first micro-TESE at a high-volume fertility center over a 10-year period. All procedures followed a standardized surgical protocol and were performed by a single experienced surgeon, ensuring uniformity in technique.
Clinical data routinely collected before surgery, such as hormone levels, semen parameters, testicular volume, and relevant medical history, were analyzed and compared between men who required only the mini-incision and those who proceeded to an extended dissection. By examining these differences, the study aims to determine whether certain patient characteristics can predict the success with the less-invasive approach.
The findings may help guide pre-surgical counseling and support more tailored surgical planning for men with severe male factor infertility
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men who underwent micro-TESE procedure from March 2015 to June 2025
Key inclusion criteria (1 listed)
- Patients with cryptozoospermia or non obstructive azoospermia that underwent a micro-TESE
Key exclusion criteria (3 listed)
- Patients with a potentially reversible cause of cryptozoospermia (i.e., presence of a varicocele, febrile illness, or recent toxin exposure)
- Patients with suspected partial genital tract obstruction (i.e post-vaso-vasostomy, post-vasoepididymostomy, and low volume cryptozoospermia with ejaculatory duct obstruction)
- Patients who have previously undergone a micro-TESE, TESA or TESE procedure
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
Successful sperm retrieval rate defined as the presence of spermatozoa during limited dissection (mini-incision) micro-TESE
Time frame: At the time of limited dissection (mini-incision)
5 secondary outcomes
Serum FSH levels
Time frame: At baseline
Serum testosterone levels
Time frame: At baseline
Testicular volume
Time frame: At baseline
Genetic abnormalities rate
Time frame: At baseline
Procedure conversion from limited to extensive micro-TESE rate
Time frame: At the time of limited dissection (mini-incision)
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 27 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Non Obstructive Azoospermia and Cryptozoospermia, 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 3 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 27 Feb 2026. 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?
Successful sperm retrieval rate defined as the presence of spermatozoa during limited dissection (mini-incision) micro-TESE (time frame: At the time of limited dissection (mini-incision)). 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 27 Feb 2026.