NCT03497728

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

December 4, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 26, 2022

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

March 13, 2018

Last Update Submit

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:

  • 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.

Sponsors & Collaborators

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Location

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

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

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

January 26, 2022

Record last verified: 2021-02

Locations

CN(1)