Non-obstructive AzoospermiaNCT02851966
Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia
A study testing mTESE in people with Non-obstructive Azoospermia, run by Mount Sinai Hospital, Canada at 3 sites in 2 countries.
Trial summary
The investigators hypothesize that sperm production varies with time in men with no sperm in semen (non-obstructive azoospermia, NOA) and that the semen protein, TEX101, is able to monitor these changes. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Non-obstructive Azoospermia
- What is being tested?
- mTESE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2016to Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosed with NOA by standard clinical means with a minimum of 2 semen tests confirming that the man is azoospermic
- Ability to understand the study and consent
- Ability to deliver semen samples
Who cannot join
- Men do not have NOA
- Cannot understand the study and consent
- Cannot provide semen samples
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Weill Cornell Medical College
New York, New York, 10065
University of California, San Francisco
San Francisco, California, 94143
About this study
The investigators hypothesize that sperm production varies with time in men with no sperm in semen (non-obstructive azoospermia, NOA) and that the semen protein, TEX101, is able to monitor these changes. The investigators further hypothesize that TEX101 levels may be used to predict the optimum time for microsurgical testicular sperm extraction (mTESE) to provide the highest successful rates of sperm retrieval.
Read the detailed description
This is a non-randomized pilot study. All men with NOA, who may or may not consider having mTESE, will be approached to enter this study.
Recruited men will have a semen test performed at the initial visit (time 0) to measure semen TEX101 levels using an ELISA assay.
For men who are not considering a mTESE to retrieve sperm, the TEX101 semen levels will be measured monthly for three months to determine the variability of semen TEX101.
For men who are considering a mTESE in an attempt to retrieve sperm, the mTESE procedure to retrieve sperm will be booked. If the level of TEX101 is detectable at time 0, then the men will have semen testing monthly. If the TEX101 is persistently detectable then the men will have surgery at the time originally scheduled. If the TEX101 drops on any subsequent test to be undetectable, then the semen testing for TEX101 will continue monthly for a maximum of 3 additional months. If the TEX101 remains undetectable for all tests, the men will have the mTESE at the end of the additional 3 months. If the TEX101 is detectable on a subsequent test, then the men will undergo an immediate mTESE (< 2 weeks).
If the initial TEX101 is undetectable, then the men will have monthly semen testing for TEX101 for a maximum of 3 additional tests. If the TEX101 remains persistently undetectable, then a mTESE will be performed as originally booked. If the TEX101 is detected on a subsequent test, then an immediate mTESE (< 2 weeks) is performed.
- Conditions
- Non-obstructive Azoospermia
- Being tested
- mTESE
- Keywords
- Non-obstructive Azoospermia, Sperm Retrieval, Infertility, Male, Semen, Biomarkers, Proteomics, Enzyme-Linked Immunosorbent Assay
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mTESEProcedure or surgery
mTESE time may be postponed or advanced.
| Study group | Role | What they receive |
|---|---|---|
| TEX101 | Other | This is a single arm study. All patients will be asked to provide multiple semen samples and all samples will be tested with TEX101 ELISA assay. Timing of mTESE maybe changed according to the assay results. Receives: Procedure: mTESE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful testicular sperm retrieval
This outcome will be measured by if sperms would be found during the procedure or if sperms would be identified in the IVF clinic.
Measured: 2 years
Secondary outcomes (2)
Natural variation in sperm counts in semen
Variation in sperm concentration in semen as measured by direct microscopic assessment of different semen samples provided by each of the participants.
Measured: 2 years
Natural variation in semen TEX101 concentration
Variation in TEX101 concentrations in semen of different semen samples provided by each of the participants as measured by the TEX101 ELISA assay.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Weill Medical College of Cornell University, McGill University, University of California, San Francisco, The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Keith Jarvi, MD, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851966
- Sponsor's protocol ID
- CAN-TEX-P1
- Status last verified
- Mar 2019
- First submitted
- 11 Jul 2016
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia
- ClinicalTrials.gov ID
- NCT02851966
- Acronym / sponsor ID
- CAN-TEX-P1
- Conditions
- Non-obstructive Azoospermia
- Keywords
- Non-obstructive Azoospermia, Sperm Retrieval, Infertility, Male, Semen, Biomarkers, Proteomics, Enzyme-Linked Immunosorbent Assay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Weill Medical College of Cornell University, McGill University, University of California, San Francisco, The Physicians' Services Incorporated Foundation
- Study start
- Feb 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- 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 investigators hypothesize that sperm production varies with time in men with no sperm in semen (non-obstructive azoospermia, NOA) and that the semen protein, TEX101, is able to monitor these changes. The investigators further hypothesize that TEX101 levels may be used to predict the optimum time for microsurgical testicular sperm extraction (mTESE) to provide the highest successful rates of sperm retrieval.
Detailed description
This is a non-randomized pilot study. All men with NOA, who may or may not consider having mTESE, will be approached to enter this study.
Recruited men will have a semen test performed at the initial visit (time 0) to measure semen TEX101 levels using an ELISA assay.
For men who are not considering a mTESE to retrieve sperm, the TEX101 semen levels will be measured monthly for three months to determine the variability of semen TEX101.
For men who are considering a mTESE in an attempt to retrieve sperm, the mTESE procedure to retrieve sperm will be booked. If the level of TEX101 is detectable at time 0, then the men will have semen testing monthly. If the TEX101 is persistently detectable then the men will have surgery at the time originally scheduled. If the TEX101 drops on any subsequent test to be undetectable, then the semen testing for TEX101 will continue monthly for a maximum of 3 additional months. If the TEX101 remains undetectable for all tests, the men will have the mTESE at the end of the additional 3 months. If the TEX101 is detectable on a subsequent test, then the men will undergo an immediate mTESE (< 2 weeks).
If the initial TEX101 is undetectable, then the men will have monthly semen testing for TEX101 for a maximum of 3 additional tests. If the TEX101 remains persistently undetectable, then a mTESE will be performed as originally booked. If the TEX101 is detected on a subsequent test, then an immediate mTESE (< 2 weeks) is performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEX101 | Other | Procedure: mTESEThis is a single arm study. All patients will be asked to provide multiple semen samples and all samples will be tested with TEX101 ELISA assay. Timing of mTESE maybe changed according to the assay results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with NOA by standard clinical means with a minimum of 2 semen tests confirming that the man is azoospermic
- Ability to understand the study and consent
- Ability to deliver semen samples
Key exclusion criteria (3 listed)
- Men do not have NOA
- Cannot understand the study and consent
- Cannot provide semen samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mTESEmTESE time may be postponed or advanced. | Procedure or surgery | TEX101 |
Primary outcome
Successful testicular sperm retrieval
Time frame: 2 years
This outcome will be measured by if sperms would be found during the procedure or if sperms would be identified in the IVF clinic.
2 secondary outcomes
Natural variation in sperm counts in semen
Time frame: 2 years
Natural variation in semen TEX101 concentration
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Keith Jarvi, MD principal investigator
Mount Sinai Hospital, Canada
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mTESE in people with Non-obstructive Azoospermia, run by Mount Sinai Hospital, Canada at 3 sites in 2 countries.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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?
Results are not available in the source record.
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 testicular sperm retrieval (time frame: 2 years). 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 Mar 2019.