OligospermiaNCT00548977
Genetic Studies Spermatogenic Failure
An observational study of Oligospermia and Azoospermia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The proposed study is designed to test the following hypotheses: 1. Mouse autosomal or X-linked genes which are exclusively expressed in mouse spermatogonia are also spermatogonia-specific in human. 2. Read more about this study
- Who is it for?
- Ages 14 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oligospermia, Azoospermia, Male Infertility
- What is being tested?
- Drawing blood to study genetic polymorphism
- How many people
- 283 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2001to Feb 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Patient visited our outpatient clinic
Who may be able to join
- Men with oligozoospermia(<2*10^7/ml) or azoospermia
Who cannot join
- Abnormal karyotypes
- Obvious genital trauma history
- Genital hernia
- Other recognizable causes of male infertility
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Oligospermia, Azoospermia, Male Infertility
- Being tested
- Drawing blood to study genetic polymorphism
- Keywords
- spermatogenesis defect, male infertility, azoospermia, oligozoospermia, Y chromosome markers, estrogen gene
- Medical subject headings
- Oligospermia, Azoospermia, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drawing blood to study genetic polymorphismOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype/phenotype correlation of Y-linked AZF candidates and estrogen-related genes
Measured: At the time of visiting OPD
Secondary outcomes (1)
Role of significant candidate genes in human spermatogenesis
Measured: At the time of drawing blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startJan 2001
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Paolin Kuo, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548977
- Sponsor's protocol ID
- NCKUH-1
- Status last verified
- Oct 2007
- First submitted
- 24 Oct 2007
- Last updated
- 25 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Studies Spermatogenic Failure
- ClinicalTrials.gov ID
- NCT00548977
- Acronym / sponsor ID
- NCKUH-1
- Conditions
- Oligospermia, Azoospermia, Male Infertility
- Keywords
- spermatogenesis defect, male infertility, azoospermia, oligozoospermia, Y chromosome markers, estrogen gene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- Feb 2005 (actual)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patient visited our outpatient clinic
Key inclusion criteria (1 listed)
- Men with oligozoospermia(<2*10^7/ml) or azoospermia
Key exclusion criteria (4 listed)
- Abnormal karyotypes
- Obvious genital trauma history
- Genital hernia
- Other recognizable causes of male infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drawing blood to study genetic polymorphism | Other | – |
Primary outcome
Genotype/phenotype correlation of Y-linked AZF candidates and estrogen-related genes
Time frame: At the time of visiting OPD
1 secondary outcome
Role of significant candidate genes in human spermatogenesis
Time frame: At the time of drawing blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2007.
Related trials for Oligospermia
Not yet recruitingPhase 4
Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
Oligoasthenoteratozoospermia, Male Infertility
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
Oligozoospermia and/or Asthenozoospermia
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
RecruitingObservational study
Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men
Azoospermia, Nonobstructive, Cryptozoospermia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolin Kuo, MD study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligospermia and Azoospermia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype/phenotype correlation of Y-linked AZF candidates and estrogen-related genes (time frame: At the time of visiting OPD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2007.