Clinical Trial: Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia

Brief 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. 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 Summary:

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.


Sponsor: Mount Sinai Hospital, Canada

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Mount Sinai Hospital, Canada

Dates:
Date Received: July 11, 2016
Date Started: February 2016
Date Completion: December 2017
Last Updated: July 28, 2016
Last Verified: July 2016