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

Not Applicable

• Conditions: Non-obstructive Azoospermia
• Interventions: Procedure: mTESE

• Registration Number: NCT02851966
• Lead Sponsor: Mount Sinai Hospital, Canada

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-12
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TEX101	mTESE	This is a single arm study. All patients will be asked to provide multiple semen samples and all samples will be tested with TEX101 ELISA assay. Timing of mTESE maybe changed according to the assay results.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

St. Mary's Hospital; 🇨🇦 Montreal, Quebec, Canada

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States