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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03497728
Other study ID # KYXM-201802
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 4, 2017
Est. completion date December 1, 2021

Study information

Verified date February 2021
Source Reproductive & Genetic Hospital of CITIC-Xiangya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this prospective study, we used Multiplex ligation-dependent probe amplification and next-generation sequencing technology to detect AZF microdeletion types accurately in selected genetic locus, and made correlation analysis with clinical treatment results.


Description:

Infertility has plagued more than 10% of the world's couples of childbearing age, of which male factors account for half. There are many causes of male infertility, including infection, genital malformations, immune dysfunction, varicocele, erectile dysfunction, drug side effect and chromosomal abnormality. Microdeletion of Azoospermia factor (AZF) in the long arm of the Y chromosome is one of the main genetic factors leading to dyszoospermia. The incidence of AZF microdeletions is 2%~19.4% among male infertile patients in Asia, which is related to the inclusion criteria, STS site selection, population and genetic background. At present, there are large numbers of studies on AZF microdeletions in male infertility, and provide rich information on male infertility. However, as the main means of detection is multiplex PCR-capillary electrophoresis method, which usually detects sequence-tagged sites(STS) such as AZFa-sY84,sY86,AZFb-sY127,sY134,AZFc- sY1191, sY1291, sY1189,sY254 and sY255, information on other loci is still lacking. In addition, the shortcomings of this method include false positive and false negative results caused by fuzzy electrophoresis strip or pollution and the presence of high repetition and a large number of palindrome in complex AZF region. Because some microdeletions can't be detected it is difficult to make an accurate judgement on the fertility of the patients. This study will use Multiplex ligation-dependent probe amplification and NGS method to improve the detection rate of AZF microdeletion, and analyze the microdeletion data and the patient's fertility results, so as to improve genetic counseling. A total of 5000 male infertility patients will be enrolled. At least 1000 parents and 1000 normal fertile men will be asked to donate their peripheral blood for DNA. In addition, in patients with azoospermia or severe oligozoospermia, the overall deletion rate of AZF is about 8.77% (1.75%-24.70%), so there are other unknown genetic factors leading to azoospermia or severe oligozoospermia. This study will also try to make a preliminary study of these factors.


Recruitment information / eligibility

Status Terminated
Enrollment 5000
Est. completion date December 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: -Male patients diagnosed with azoospermia and severe oligozoospermia. Exclusion Criteria: 1. Klinefelter Syndrome ; 2. Structural chromosome aberrations; 3. Obstructive anspermia; 4. Male infertility caused by endocrine factors; 5. Do not meet requirements for acquisition, processing and preservation of samples; 6. After sampling, it doesn't conform to the standard of quality control, or other experimental conditions that don't meet the test requirement; 7. Unable to obtain patient history;

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha Hunan

Sponsors (7)

Lead Sponsor Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya Anhui Provincial Hospital, Henan Provincial People's Hospital, Tang-Du Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First Affiliated Hospital of Anhui Medical University, The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary frequency of mirodeletion The propotion of azoospermia patients with AZF mirodeletion through study completion, an average of 1 year