Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia
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|ClinicalTrials.gov Identifier: NCT02851966|
Recruitment Status : Enrolling by invitation
First Posted : August 2, 2016
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-obstructive Azoospermia||Procedure: mTESE||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
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 time may be postponed or advanced.
- 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.
- Natural variation in sperm counts in semen [ Time Frame: 2 years ]Variation in sperm concentration in semen as measured by direct microscopic assessment of different semen samples provided by each of the participants.
- Natural variation in semen TEX101 concentration [ Time Frame: 2 years ]Variation in TEX101 concentrations in semen of different semen samples provided by each of the participants as measured by the TEX101 ELISA assay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851966
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|St. Mary's Hospital|
|Montreal, Quebec, Canada, QC H3T 1M5|
|Principal Investigator:||Keith Jarvi, MD||Mount Sinai Hospital, Canada|