Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia
NCT ID: NCT02851966
Last Updated: 2019-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2016-02-29
2020-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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TEX101
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.
mTESE
mTESE time may be postponed or advanced.
Interventions
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mTESE
mTESE time may be postponed or advanced.
Eligibility Criteria
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Inclusion Criteria
* Ability to understand the study and consent
* Ability to deliver semen samples
Exclusion Criteria
* Cannot understand the study and consent
* Cannot provide semen samples
18 Years
MALE
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Weill Medical College of Cornell University
OTHER
McGill University
OTHER
University of California, San Francisco
OTHER
The Physicians' Services Incorporated Foundation
OTHER
Mount Sinai Hospital, Canada
OTHER
Responsible Party
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Principal Investigators
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Keith Jarvi, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Hospital, Canada
Locations
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University of California, San Francisco
San Francisco, California, United States
Weill Cornell Medical College
New York, New York, United States
St. Mary's Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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CAN-TEX-P1
Identifier Type: -
Identifier Source: org_study_id
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