Treatment of Severe Male Infertility - Predictive Factors (Imaging) (TESE-MRI)

October 27, 2023 updated by: Rauni Klami, Turku University Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sperm recovery rate in non-obstructive azoospermia (NOA) men is 43% in Turku University Hospital, depending on the diagnosis leading to NOA. To date, there are no known parameters known to differentiate between successful and unsuccessful sperm recovery.

MRI is performed on men prior to the operation, and the objective is to compare the functional parameters assessed by magnetic resonance imaging between the group of men with positive and the men with negative sperm recovery in testicular microdissection sperm extraction (MD-TESE).

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Turku University Hospital, Dept of Obst and Gyn
      • Turku, Finland
        • Dept of Obst and Gyn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Azoospermic men scheduled for MD-TESE

Description

Inclusion Criteria:

  • non obstructive azospermia

Exclusion Criteria:

  • malignancy
  • contraindication for fertility treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MRI Positive
Men with sperm found in MD-TESE
Diagnostic test: MRI
Pelvis MRI
MRI Negative
Men with no sperm found in MD-TESE
Diagnostic test: MRI
Pelvis MRI
Control group
No intervention, fertile
Diagnostic test: MRI
Pelvis MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional difference in testicular MRI depending on MD-TESE outcome (=sperm recovery)
Time Frame: Baseline/ pre-invention
ADC differences by diagnosis and outcome
Baseline/ pre-invention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Study Director: Antti Perheentupa, MD,PhD, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimated)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESE-MRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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