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

Primary Purpose

Non-obstructive Azoospermia

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
mTESE
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non-obstructive Azoospermia focused on measuring Non-obstructive Azoospermia, Sperm Retrieval, Infertility, Male, Semen, Biomarkers, Proteomics, Enzyme-Linked Immunosorbent Assay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco
  • Weill Cornell Medical College
  • St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TEX101

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 11, 2016
Last Updated
March 8, 2019
Sponsor
Mount Sinai Hospital, Canada
Collaborators
Canadian Institutes of Health Research (CIHR), Weill Medical College of Cornell University, McGill University, University of California, San Francisco, The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02851966
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
Canadian Institutes of Health Research (CIHR), Weill Medical College of Cornell University, McGill University, University of California, San Francisco, The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-obstructive Azoospermia
Keywords
Non-obstructive Azoospermia, Sperm Retrieval, Infertility, Male, Semen, Biomarkers, Proteomics, Enzyme-Linked Immunosorbent Assay

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEX101
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
mTESE
Intervention Description
mTESE time may be postponed or advanced.
Primary Outcome Measure Information:
Title
Successful testicular sperm retrieval
Description
This outcome will be measured by if sperms would be found during the procedure or if sperms would be identified in the IVF clinic.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Natural variation in sperm counts in semen
Description
Variation in sperm concentration in semen as measured by direct microscopic assessment of different semen samples provided by each of the participants.
Time Frame
2 years
Title
Natural variation in semen TEX101 concentration
Description
Variation in TEX101 concentrations in semen of different semen samples provided by each of the participants as measured by the TEX101 ELISA assay.
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Jarvi, MD
Organizational Affiliation
Mount Sinai Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
St. Mary's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
QC H3T 1M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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