Clinical trial NCT02851966: Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia
Official title: Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-obstructive Azoospermia
Keywords: Non-obstructive Azoospermia
Sperm Retrieval
Infertility, Male
Semen
Biomarkers
Proteomics
Enzyme-Linked Immunosorbent Assay
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Weill Medical College of Cornell University
name: McGill University
name: University of California, San Francisco
name: The Physicians' Services Incorporated Foundation
First posted: 2016-08-02
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful testicular sperm retrieval
timeFrame: 2 years
Secondary outcomes:
measure: Natural variation in sperm counts in semen
timeFrame: 2 years
measure: Natural variation in semen TEX101 concentration
timeFrame: 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Montreal
country: Canada
facility: St. Mary's Hospital
state: Quebec
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Keith Jarvi, MD
role: PRINCIPAL_INVESTIGATOR
References: