NCT00548977

Brief Summary

The proposed study is designed to test the following hypotheses:

  1. 1.Mouse autosomal or X-linked genes which are exclusively expressed in mouse spermatogonia are also spermatogonia-specific in human.
  2. 2.Severe spermatogenic defect, especially hypospermatogenesis or SCOS, is caused by an intrinsic defect in germ line stem cell or speramtogenia.
  3. 3.Spermatogonia-specific genes are caudate genes for human spermatogenic defect, especially for hypospermatogenesis or SCOS.
  4. 4.For a significant fraction of cases with severe spermatogenic defect, the sterile genes are transmitted via multifactorial inheritance mode.
  5. 5.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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
283

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

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

January 1, 2001

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
Last Updated

October 25, 2007

Status Verified

October 1, 2007

First QC Date

October 24, 2007

Last Update Submit

October 24, 2007

Conditions

OligospermiaAzoospermiaMale Infertility

Keywords

spermatogenesis defectmale infertilityazoospermiaoligozoospermiaY chromosome markersestrogen gene

Outcome Measures

Primary Outcomes (1)

  • Genotype/phenotype correlation of Y-linked AZF candidates and estrogen-related genes

    At the time of visiting OPD

Secondary Outcomes (1)

  • Role of significant candidate genes in human spermatogenesis

    At the time of drawing blood

Interventions

Drawing blood to study genetic polymorphismOTHER

Eligibility Criteria

Age14 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patient visited our outpatient clinic

You may qualify if:

  • Men with oligozoospermia(\<2\*10\^7/ml) or azoospermia

You may not qualify if:

  • Abnormal karyotypes
  • Obvious genital trauma history
  • Genital hernia
  • Other recognizable causes of male infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

OligospermiaAzoospermiaInfertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Paolin Kuo, MD

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

January 1, 2001

Study Completion

February 1, 2005

Last Updated

October 25, 2007

Record last verified: 2007-10

Locations

TW(1)