NCT02851966

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

3.8 years

First QC Date

July 11, 2016

Last Update Submit

March 8, 2019

Conditions

Non-obstructive Azoospermia

Keywords

Non-obstructive AzoospermiaSperm RetrievalInfertility, MaleSemenBiomarkersProteomicsEnzyme-Linked Immunosorbent Assay

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Natural variation in sperm counts in semen

    2 years

  • Natural variation in semen TEX101 concentration

    2 years

Study Arms (1)

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

mTESEPROCEDURE

mTESE time may be postponed or advanced.

TEX101

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Men do not have NOA
  • Cannot understand the study and consent
  • Cannot provide semen samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

St. Mary's Hospital

Montreal, Quebec, QC H3T 1M5, Canada

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Keith Jarvi, MD

    Mount Sinai Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

August 2, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

CA(1)US(2)