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

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ClinicalTrials.gov Identifier: NCT02851966
Recruitment Status : Unknown
Verified July 2016 by Mount Sinai Hospital, Canada.
Recruitment status was:  Enrolling by invitation
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-obstructive Azoospermia Procedure: mTESE Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia
Study Start Date : February 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Successful testicular sperm retrieval [ Time Frame: 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 :
  1. Natural variation in sperm counts in semen [ Time Frame: 2 years ]
    Variation in sperm concentration in semen as measured by direct microscopic assessment of different semen samples provided by each of the participants.

  2. Natural variation in semen TEX101 concentration [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851966


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Canada, Quebec
St. Mary's Hospital
Montreal, Quebec, Canada, QC H3T 1M5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Canadian Institutes of Health Research (CIHR)
Weill Medical College of Cornell University
McGill University
University of California, San Francisco
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Keith Jarvi, MD Mount Sinai Hospital, Canada

Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02851966     History of Changes
Other Study ID Numbers: CAN-TEX-P1
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mount Sinai Hospital, Canada:
Non-obstructive Azoospermia
Sperm Retrieval
Infertility, Male
Semen
Biomarkers
Proteomics
Enzyme-Linked Immunosorbent Assay

Additional relevant MeSH terms:
Azoospermia
Infertility, Male
Infertility
Genital Diseases, Male