NCT03497728

Terminated

Detection of Microdeletions in the Azoospermia Factor (AZF) ...

Reproductive & Genetic Hospital of CITIC-Xiangya Source

Reproductive & Genetic Hospital of CITIC-Xiangya

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

KYXM-201802

Study Type

observational

Actual enrollment (reported)

5,000

Locations

1 country

Sites

1

Timeline

Study Start

December 4, 2017

Actual (reported)

Primary Completion

September 1, 2021

Actual (reported)

Study Completion

December 1, 2021

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 5,000 participants
Study completion date: December 1, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 4, 2017
Actual (reported)
First Submitted
March 13, 2018
Actual (reported)
First Posted
April 13, 2018
Actual (reported)
Primary Completion
September 1, 2021
Actual (reported)
Study Completion
December 1, 2021
Actual (reported)

Last Updated: January 26, 2022
Status Verified: February 2021
Last Update Submitted: January 10, 2022

Conditions

Azoospermia or Severe Oligozoospermia

Outcome Measures

Primary Outcomes (1)

frequency of mirodeletion
The propotion of azoospermia patients with AZF mirodeletion
through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+

Sexmale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Male patients diagnosed with azoospermia and severe oligozoospermia.

You may qualify if:

Male patients diagnosed with azoospermia and severe oligozoospermia.

You may not qualify if:

Sponsors & Collaborators

Henan Provincial People's Hospital
Othercollaborator
Tang-Du Hospital
Othercollaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Biospecimen

Retention: SAMPLES WITH DNA

Blood is collected in the morning from each patient and then stored at -20℃. Blood specimen is sent to the Lab in Jabrehoo for DNA extraction.

MeSH Terms

Conditions

AzoospermiaOligospermia

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

Yueqiu Tan
Reproductive & Genetic Hospital of CITIC-Xiangya
STUDY CHAIR

Enrollment

5,000 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: FAMILY BASED
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 13, 2018

First Posted

April 13, 2018

Study Start

December 4, 2017

Actual (reported)

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;

Contact the study team to confirm eligibility.

Otherlead

The First Affiliated Hospital of Anhui Medical University

Othercollaborator

The Affiliated Hospital of Inner Mongolia Medical University

Othercollaborator

Anhui Provincial Hospital

Governmentcollaborator

The First Hospital of Jilin University

Othercollaborator

Primary Completion

September 1, 2021

Actual (reported)

Study Completion

December 1, 2021

Actual (reported)

Last Updated

January 26, 2022

Record last verified: 2021-02

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT03497728
Data provider: ClinicalTrials.gov
Source updated: 2022-01-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:17 UTC

Locations

CN(1)

Study Stopped

Detection of Microdeletions in the Azoospermia Factor (AZF) Regions in Infertile Male Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations