- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07286279
Identifying Candidates for Limited Dissection at Microdissection TESE.
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:
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H4P 2S4
- Clinique ovo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with cryptozoospermia or non obstructive azoospermia that underwent a micro-TESE
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
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At the time of limited dissection (mini-incision)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum FSH levels
Time Frame: At baseline
|
At baseline
|
|
Serum testosterone levels
Time Frame: At baseline
|
At baseline
|
|
Testicular volume
Time Frame: At baseline
|
At baseline
|
|
Genetic abnormalities rate
Time Frame: At baseline
|
At baseline
|
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Procedure conversion from limited to extensive micro-TESE rate
Time Frame: At the time of limited dissection (mini-incision)
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At the time of limited dissection (mini-incision)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mini incision Micro-TESE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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