Male InfertilityTESE-MRINCT02931721
Treatment of Severe Male Infertility - Predictive Factors (Imaging)
An observational study of Male Infertility, run by Turku University Hospital at 2 sites in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- MRI
- How many people
- 30 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Nov 2016to Jul 2023
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Azoospermic men scheduled for MD-TESE
Who may be able to join
- non obstructive azospermia
Who cannot join
- malignancy
- contraindication for fertility treatment
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Turku University Hospital, Dept of Obst and Gyn
Turku, 20520
Dept of Obst and Gyn
Turku
About this study
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).
Read the 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).
- Conditions
- Male Infertility
- Being tested
- MRI
- Keywords
- Azospermia, Micro Dissection Testicular Sperm Extraction, Male infertility, Testis, MRI
- Medical subject headings
- Infertility, Male, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Pelvis MRI
| Study group | Role | What they receive |
|---|---|---|
| MRI Positive | Men with sperm found in MD-TESE Receives: Diagnostic Test: MRI | |
| MRI Negative | Men with no sperm found in MD-TESE Receives: Diagnostic Test: MRI | |
| Control group | No intervention, fertile Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional difference in testicular MRI depending on MD-TESE outcome (=sperm recovery)
ADC differences by diagnosis and outcome
Measured: Baseline/ pre-invention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start1 Nov 2016
- Primary completionJul 2023
- Study completionJul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rauni Klami, Turku University Hospital
- Investigators
- Antti Perheentupa, MD,PhD, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931721
- Sponsor's protocol ID
- TESE-MRI
- Acronym
- TESE-MRI
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2016
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe Male Infertility - Predictive Factors (Imaging)
- ClinicalTrials.gov ID
- NCT02931721
- Acronym / sponsor ID
- TESE-MRI / TESE-MRI
- Conditions
- Male Infertility
- Keywords
- Azospermia, Micro Dissection Testicular Sperm Extraction, Male infertility, Testis, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- Jul 2023 (actual)
- Study completion
- Jul 2023 (actual)
- First posted
- 13 Oct 2016 (estimated)
- 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.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MRI Positive | – | Diagnostic Test: MRIMen with sperm found in MD-TESE |
| MRI Negative | – | Diagnostic Test: MRIMen with no sperm found in MD-TESE |
| Control group | – | Diagnostic Test: MRINo intervention, fertile |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Azoospermic men scheduled for MD-TESE
Key inclusion criteria (1 listed)
- non obstructive azospermia
Key exclusion criteria (2 listed)
- malignancy
- contraindication for fertility treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIPelvis MRI | Diagnostic test | Control group, MRI Negative, MRI Positive |
Primary outcome
Functional difference in testicular MRI depending on MD-TESE outcome (=sperm recovery)
Time frame: Baseline/ pre-invention
ADC differences by diagnosis and outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Antti Perheentupa, MD,PhD study director
Turku University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Turku University Hospital at 2 sites in Finland.
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 2 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: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional difference in testicular MRI depending on MD-TESE outcome (=sperm recovery) (time frame: Baseline/ pre-invention). 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 1 Nov 2023.