Non-obstructive Azoospermia
Conditions
Keywords
Non-obstructive Azoospermia, Sperm Retrieval, Infertility, Male, Semen, Biomarkers, Proteomics, Enzyme-Linked Immunosorbent Assay
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 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.
Interventions
PROCEDUREmTESE
mTESE time may be postponed or advanced.
Sponsors
Canadian Institutes of Health Research (CIHR)
Weill Medical College of Cornell University
McGill University
University of California, San Francisco
The Physicians' Services Incorporated Foundation
Mount Sinai Hospital, Canada
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful testicular sperm retrieval | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Natural variation in sperm counts in semen | 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 | 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. |
Countries
Canada, United States
Outcome results
None listed