NCT02756923

Brief Summary

Investigative trial to evaluate the role of a glial cell lined derived neurotrophic factor (GDNF) in regulation of spermatogonial renewal and testicular function. Goal of the trial is to provide greater information on the mechanisms that effect stem spermatogonial maintenance renewal and proliferation in its relation to male infertility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

7.6 years

First QC Date

April 13, 2016

Last Update Submit

March 23, 2023

Conditions

Male Infertility

Keywords

Male InfertilitySpermatogonial stem cell

Outcome Measures

Primary Outcomes (1)

  • Levels of glial cell line derived neurotrophic factor (GDNF) in normal testis compared to abnormal testicular tissue obtained from infertile patients

    Levels of glial cell line derived neurotrophic factor (GDNF) in normal testis compared to abnormal testicular tissue.

    five years

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy males undergoing testicular biopsy by any urologic surgeon at Weill Cornell Medicine.

You may qualify if:

  • undergoing testicular biopsy at Weill Cornell Medicine/New York Presbyterian

You may not qualify if:

  • females and any males outside of the age parameter of 18-75 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (2)

  • Singh D, Paduch DA, Schlegel PN, Orwig KE, Mielnik A, Bolyakov A, Wright WW. The production of glial cell line-derived neurotrophic factor by human sertoli cells is substantially reduced in sertoli cell-only testes. Hum Reprod. 2017 May 1;32(5):1108-1117. doi: 10.1093/humrep/dex061.

    PMID: 28369535RESULT

  • Paduch DA, Hilz S, Grimson A, Schlegel PN, Jedlicka AE, Wright WW. Aberrant gene expression by Sertoli cells in infertile men with Sertoli cell-only syndrome. PLoS One. 2019 May 9;14(5):e0216586. doi: 10.1371/journal.pone.0216586. eCollection 2019.

    PMID: 31071133RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Testicular tissue, Blood

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Peter N Schlegel, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 29, 2016

Study Start

April 1, 2012

Primary Completion

November 7, 2019

Study Completion

December 5, 2019

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)