Azoospermia or Severe OligozoospermiaNCT03497728
Detection of Microdeletions in the Azoospermia Factor (AZF) Regions in Infertile Male Patients
An observational study of Azoospermia or Severe Oligozoospermia, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Azoospermia or Severe Oligozoospermia
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2017to 1 Dec 2021
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients diagnosed with azoospermia and severe oligozoospermia.
Who may be able to join
- -Male patients diagnosed with azoospermia and severe oligozoospermia.
Who cannot join
- Klinefelter Syndrome ;
- Structural chromosome aberrations；
- Obstructive anspermia;
- Male infertility caused by endocrine factors;
- Do not meet requirements for acquisition, processing and preservation of samples；
- After sampling, it doesn't conform to the standard of quality control, or other experimental conditions that don't meet the test requirement；
- Unable to obtain patient history;
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410000
About this study
Official title: Detection of Microdeletions in the Azoospermia Factor (AZF) Regions on the Human Y Chromosome in Infertile Male Patients
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.
Read the detailed 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.
- Conditions
- Azoospermia or Severe Oligozoospermia
- Medical subject headings
- Azoospermia, Oligospermia
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of mirodeletion
The propotion of azoospermia patients with AZF mirodeletion
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start4 Dec 2017
- Primary completion1 Sep 2021
- Study completion1 Dec 2021
Why it stopped: halted prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azoospermia or Severe OligozoospermiaStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Provincial Hospital, Tang-Du Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Henan Provincial People's Hospital, The First Affiliated Hospital of Anhui Medical University, The First Hospital of Jilin University
- Responsible party
- Sponsor
- Investigators
- Yueqiu Tan, Study chair, Reproductive & Genetic Hospital of CITIC-Xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497728
- Sponsor's protocol ID
- KYXM-201802
- Status last verified
- Feb 2021
- First submitted
- 13 Mar 2018
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Microdeletions in the Azoospermia Factor (AZF) Regions on the Human Y Chromosome in Infertile Male Patients
- ClinicalTrials.gov ID
- NCT03497728
- Acronym / sponsor ID
- KYXM-201802
- Conditions
- Azoospermia or Severe Oligozoospermia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: halted prematurely
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Collaborators
- Anhui Provincial Hospital, Tang-Du Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Henan Provincial People's Hospital, The First Affiliated Hospital of Anhui Medical University, The First Hospital of Jilin University
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 13 Apr 2018 (actual)
- 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.
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.
Detailed 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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients diagnosed with azoospermia and severe oligozoospermia.
Key inclusion criteria (1 listed)
- -Male patients diagnosed with azoospermia and severe oligozoospermia.
Key exclusion criteria (7 listed)
- Klinefelter Syndrome ;
- Structural chromosome aberrations；
- Obstructive anspermia;
- Male infertility caused by endocrine factors;
- Do not meet requirements for acquisition, processing and preservation of samples；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
frequency of mirodeletion
Time frame: through study completion, an average of 1 year
The propotion of azoospermia patients with AZF mirodeletion
Results and safety
The study was stopped early (reason given: halted prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
Related trials for Azoospermia or Severe Oligozoospermia
Recruiting
Fertility Restoration With Autografting of Cryopreserved Immature Testicular Tissue
Azoospermia or Severe Oligozoospermia, Infertility
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.
Yueqiu Tan study chair
Reproductive & Genetic Hospital of CITIC-Xiangya
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 Azoospermia or Severe Oligozoospermia, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
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 7 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: stopped early, as of the sponsor's last update on 26 Jan 2022. 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 China. 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 was stopped early (reason given: halted prematurely). Results are not available in the source record.
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?
frequency of mirodeletion (time frame: through study completion, an average of 1 year). 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 26 Jan 2022.