Use of Semen TEX101 to Improve Sperm Retrieval Rates for... | NCT02851966

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

NCT02851966

Sponsor

Mount Sinai Hospital, Canada

Status

Unknown status

Last Update Posted

Mar 12, 2019Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Non-obstructive Azoospermia

Interventions

mTESE

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jul 11, 2016

First Submission Date that Met QC Criteria

Jul 28, 2016

First Posted Date

Aug 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2019

Last Update Posted Date

Mar 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Mount Sinai Hospital, CanadaOTHER

Collaborators

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV
Weill Medical College of Cornell University	OTHER
McGill University	OTHER
University of California, San Francisco

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TEX101	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mTESE	Procedure	mTESE time may be postponed or advanced.	TEX101

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keith Jarvi, MD	Mount Sinai Hospital, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States
Weill Cornell Medical College

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility

Browse Leaves

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Browse Branches

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