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

Non-obstructive Azoospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02851966
• Other study ID #: CAN-TEX-P1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Azoospermia
• Non-obstructive Azoospermia

Intervention

Procedure:
• mTESE
mTESE time may be postponed or advanced.

Locations

Country	Name	City	State
Canada	St. Mary's Hospital	Montreal	Quebec
United States	Weill Cornell Medical College	New York	New York
United States	University of California, San Francisco	San Francisco	California

Sponsors (6)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Canadian Institutes of Health Research (CIHR), McGill University, The Physicians' Services Incorporated Foundation, University of California, San Francisco, Weill Medical College of Cornell University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful testicular sperm retrieval	This outcome will be measured by if sperms would be found during the procedure or if sperms would be identified in the IVF clinic.	2 years
Secondary	Natural variation in sperm counts in semen	Variation in sperm concentration in semen as measured by direct microscopic assessment of different semen samples provided by each of the participants.	2 years
Secondary	Natural variation in semen TEX101 concentration	Variation in TEX101 concentrations in semen of different semen samples provided by each of the participants as measured by the TEX101 ELISA assay.	2 years