Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | February 2016 |
| End Date: | December 2020 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Men do not have NOA
- Cannot understand the study and consent
- Cannot provide semen samples
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