- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00548977
Genetic Studies Spermatogenic Failure
October 24, 2007 updated by: National Cheng-Kung University Hospital
The proposed study is designed to test the following hypotheses:
- Mouse autosomal or X-linked genes which are exclusively expressed in mouse spermatogonia are also spermatogonia-specific in human.
- Severe spermatogenic defect, especially hypospermatogenesis or SCOS, is caused by an intrinsic defect in germ line stem cell or speramtogenia.
- Spermatogonia-specific genes are caudate genes for human spermatogenic defect, especially for hypospermatogenesis or SCOS.
- For a significant fraction of cases with severe spermatogenic defect, the sterile genes are transmitted via multifactorial inheritance mode.
- For some cases with severe spermatogenic defect, mutations of spermatogonia- specific genes may be transmitted in the X-linked recessive, autosomal recessive, or autosomal dominant mode.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Between 2% and 12% of couples worldwide are affected by reduced fertility.
Men who have defects in sperm production (spermatogenic defect) account for about half of these cases.
In Drosophila and mouse, targeted disruptions of numerous sterility- associated genes have been created.
Physiological studies in the Drosophila and in mouse also indicate that spermatogenesis is subjected to complex regulation, and male infertility may result from aberrant regulatory events.
In the human being, deletions of the Y chromosome account for only 10% of cases with spermatogenic defect, and etiologies of remaining 90% of cases are still unknown.
It is evident that multiple genes are involved in male infertility.
For cases with severe spermatogenic defect , testicular histology shows either decreased number of germ cells in all developmental stages (hypospermatogenesis) or complete absence of germ cells (Sertoli cell only syndrome or SCOS).
It appears that there is an intrinsic defect which causes depletion of germ-line stem cells (spermatogonia) for cases with hypospermatogenesis or SCOS.
Of 25 genes exclusively expressed in mouse spermatogonia, 3 are Y-linked, 10 are X-linked, and only 12 are distributed on autosomes.
Study Type
Observational
Enrollment (Actual)
283
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tainan, Taiwan
- National Cheng-Kung University Hospital
-
-
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
12 years to 58 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Patient visited our outpatient clinic
Description
Inclusion Criteria:
- Men with oligozoospermia(<2*10^7/ml) or azoospermia
Exclusion Criteria:
- Abnormal karyotypes
- Obvious genital trauma history
- Genital hernia
- Other recognizable causes of male infertility
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Genotype/phenotype correlation of Y-linked AZF candidates and estrogen-related genes
Time Frame: At the time of visiting OPD
|
At the time of visiting OPD
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Role of significant candidate genes in human spermatogenesis
Time Frame: At the time of drawing blood
|
At the time of drawing blood
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Paolin Kuo, MD
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
January 1, 2001
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
October 24, 2007
First Submitted That Met QC Criteria
October 24, 2007
First Posted (Estimate)
October 25, 2007
Study Record Updates
Last Update Posted (Estimate)
October 25, 2007
Last Update Submitted That Met QC Criteria
October 24, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCKUH-1
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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