TEX101 for Nonobstructive Azoospermia

N/A

Waitlist Available

Led By Keith Jarvi, MD

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Nonobstructive Azoospermia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful testicular sperm retrieval

Secondary study objectives

Natural variation in semen TEX101 concentration

Natural variation in sperm counts in semen

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TEX101Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mTESE

2017

N/A

~110

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