NCT02931721

Brief Summary

Testes of men with non-obstructive azoospermia (NOA) are imaged using MRI to find potential differences depending on the outcome, ie. sperm recovery in consequent microdissection testicular sperm extraction (MD-TESE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 5, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

6.7 years

First QC Date

October 5, 2016

Last Update Submit

October 27, 2023

Conditions

Male Infertility

Keywords

AzospermiaMicro Dissection Testicular Sperm ExtractionMale infertilityTestisMRI

Outcome Measures

Primary Outcomes (1)

  • Functional difference in testicular MRI depending on MD-TESE outcome (=sperm recovery)

    ADC differences by diagnosis and outcome

    Baseline/ pre-invention

Study Arms (3)

MRI Positive

Men with sperm found in MD-TESE

Diagnostic Test: MRI

MRI Negative

Men with no sperm found in MD-TESE

Diagnostic Test: MRI

Control group

No intervention, fertile

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

Pelvis MRI

Control groupMRI NegativeMRI Positive

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Azoospermic men scheduled for MD-TESE

You may qualify if:

  • non obstructive azospermia

You may not qualify if:

  • malignancy
  • contraindication for fertility treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Turku University Hospital, Dept of Obst and Gyn

Turku, 20520, Finland

Location

Dept of Obst and Gyn

Turku, Finland

Location

MeSH Terms

Conditions

Infertility, MaleAzoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Antti Perheentupa, MD,PhD

    Turku University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 13, 2016

Study Start

November 1, 2016

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)