- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02756923
Regulation of Stem Spermatogonia in the Mature Testis
March 23, 2023 updated by: Weill Medical College of Cornell University
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.
Study Overview
Status
Completed
Conditions
Detailed Description
An essential requirement for sustaining male fertility is maintaining an adequate number of stem spermatogonia, the foundation of spermatogenesis.
To achieve this, when the stem cells divide, some progeny must remain stem spermatogonia while other progeny differentiate.
It is obvious that the correct balance between self-renewing replication and differentiation of stem spermatogonia is crucial to male fertility, and there is a indirect evidence that GDNF plays an important role in maintaining this balance in the normal mature testis.
However, almost nothing is known about the in vivo regulation of this balance in the mature organ, of the specific function of GDNF in the adult testis, or if physiological changes in GDNF expression significantly affect the replication or differentiation of the stem cells.
To address these critical issues, a unique mouse model that allows GDNF signaling to the stem spermatogonia to be specifically and reversibly inhibited in vivo by an ATP antagonist.
With this model, the first direct evidence that GDNF is required for maintaining the stem spermatogonial pool in a normal mature testis.
Additionally, the investigators have shown that when inhibition of GDNF signaling is reversed, the stem cells begin to rebuild the stem cell pool.
Importantly, our data demonstrate that some stem spermatogonia are lost when GDNF signaling is inhibited for as little as 2 days, while other stem cells survive for up to 11 days.
This suggests that factors intrinsic or extrinsic to the stem cells modulate the response to GDNF.
Using this new mouse model the mechanisms responsible for the loss of stem spermatogonia proliferation and regeneration will be investigated along with GDNF signaling and inhibition.
At the end of all of this these studies will be done on waste tissue obtained from normal men and men with infertility who otherwise have testicular surgery for therapeutic purposes.
Study Type
Observational
Enrollment (Actual)
142
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thomas Flynn
- Phone Number: 2127464739
- Email: thf3001@med.cornell.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Healthy males undergoing testicular biopsy by any urologic surgeon at Weill Cornell Medicine.
Description
Inclusion Criteria:
- undergoing testicular biopsy at Weill Cornell Medicine/New York Presbyterian
Exclusion Criteria:
- females and any males outside of the age parameter of 18-75 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of glial cell line derived neurotrophic factor (GDNF) in normal testis compared to abnormal testicular tissue obtained from infertile patients
Time Frame: five years
|
Levels of glial cell line derived neurotrophic factor (GDNF) in normal testis compared to abnormal testicular tissue.
|
five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: PLoS One. 2019 Aug 20;14(8):e0221648.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
November 7, 2019
Study Completion (Actual)
December 5, 2019
Study Registration Dates
First Submitted
April 13, 2016
First Submitted That Met QC Criteria
April 27, 2016
First Posted (Estimate)
April 29, 2016
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1202012193
- 1P50HD096723-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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