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

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.

Study Overview

• Status: Unknown
• Conditions: Non-obstructive Azoospermia
• Intervention / Treatment: Procedure: mTESE

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, QC H3T 1M5
      • St. Mary's Hospital
• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TEX101; 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.	Procedure: mTESE; mTESE time may be postponed or advanced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: McGill University; Canadian Institutes of Health Research (CIHR); Weill Medical College of Cornell University; University of California, San Francisco; The Physicians' Services Incorporated Foundation
• Investigators: Principal Investigator: Keith Jarvi, MD, Mount Sinai Hospital, Canada

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Biomarkers; Proteomics; Semen; Infertility, Male; Enzyme-Linked Immunosorbent Assay; Non-obstructive Azoospermia; Sperm Retrieval
• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Azoospermia
• Other Study ID Numbers: CAN-TEX-P1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided