Fertility DisordersNCT03250195
Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
A study testing PET/MRI in people with Fertility Disorders, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of the study is to examine the value of the new MRI techniques (spectroscopy and DWI), and FDG-PET in prognostication of male infertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Aug 2017to 7 Aug 2021
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 year old males referred to fertility treatment at Rigshospitalet, Denmark. 10 men with a normal sperm count and 10 men with no sperm cells in the ejaculate will be included. The patients shall be able to understand the patient information and be able to give informed consent.
Who cannot join
- Severe claustrophobia Age: less than 18 or above 40 Severe obesity (> 140 kg) Pacemaker or other electronic in-operated devices Non-MR compatible metallic devices Malignant testicular tumors suspected at clinical examination or ultrasound Infectious testicular diseases
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to examine the value of the new MRI techniques (spectroscopy and DWI), and FDG-PET in prognostication of male infertility.
Read the detailed description
The diagnostic workup of male infertility includes medical history, physical examination and semen analysis. In severe cases further workup includes testicular ultrasound, analysis of genes and hormones and in a few cases testicular biopsies are necessary.
Ultrasound is the first choice of imaging, but new MRI and PET techniques can provide additional information.
Research indicates that new MRI techniques can measure the activity of the testicular sperm cell production non-invasively and FDG-PET can measure the testicular metabolism with a radioactively marked glucose analog (FDG). These imaging modalities are combined in a PET/MRI and we wish to perform a PET/MRI in 10 men with normal sperm counts and 10 men with low sperm counts in order to evaluate whether a PET/MRI can distinguish testicles with and without sperm cell production. We hope that this new non-invasive technique can replace the need for invasive biopsies and will be able to target the harvesting of sperm cells in fertility treatment.
- Conditions
- Fertility Disorders
- Being tested
- PET/MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDiagnostic test
PET/MRI scan
| Study group | Role | What they receive |
|---|---|---|
| PET/MRI | Other | All participants will have a PET/MRI performed Receives: Diagnostic Test: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax (maximum standardized uptake value)
The SUV is the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.
Measured: 1 year
Testicular metabolite concentrations measured by MRI spectroscopy.
MR spectroscopy is a non-invasive, ionizing-radiation-free analytical technique that has been used to study metabolic changes in different tissues. The unit is p.p.m.
Measured: 1 year
Testicular apparent diffusion coefficient
Diffusion-weighted magnetic resonance imaging (DW MRI) provides image contrast that is dependent on the random microscopic motion of water protons, which may be substantially altered by different pathological process.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start7 Aug 2017
- Primary completion7 Aug 2021
- Study completion7 Aug 2021
Why it stopped: Insufficient inclusion of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Madeleine Risør, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Louise Risør, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250195
- Sponsor's protocol ID
- H-17013319
- Status last verified
- Nov 2022
- First submitted
- 7 Aug 2017
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results will be published in international journals
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
- ClinicalTrials.gov ID
- NCT03250195
- Acronym / sponsor ID
- H-17013319
- Conditions
- Fertility Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient inclusion of patients
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 7 Aug 2021 (actual)
- Study completion
- 7 Aug 2021 (actual)
- First posted
- 15 Aug 2017 (actual)
- 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.
The aim of the study is to examine the value of the new MRI techniques (spectroscopy and DWI), and FDG-PET in prognostication of male infertility.
Detailed description
The diagnostic workup of male infertility includes medical history, physical examination and semen analysis. In severe cases further workup includes testicular ultrasound, analysis of genes and hormones and in a few cases testicular biopsies are necessary.
Ultrasound is the first choice of imaging, but new MRI and PET techniques can provide additional information.
Research indicates that new MRI techniques can measure the activity of the testicular sperm cell production non-invasively and FDG-PET can measure the testicular metabolism with a radioactively marked glucose analog (FDG). These imaging modalities are combined in a PET/MRI and we wish to perform a PET/MRI in 10 men with normal sperm counts and 10 men with low sperm counts in order to evaluate whether a PET/MRI can distinguish testicles with and without sperm cell production. We hope that this new non-invasive technique can replace the need for invasive biopsies and will be able to target the harvesting of sperm cells in fertility treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MRI | Other | Diagnostic Test: PET/MRIAll participants will have a PET/MRI performed |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-40 year old males referred to fertility treatment at Rigshospitalet, Denmark. 10 men with a normal sperm count and 10 men with no sperm cells in the ejaculate will be included. The patients shall be able to understand the patient information and be able to give informed consent.
Key exclusion criteria (1 listed)
- Severe claustrophobia Age: less than 18 or above 40 Severe obesity (> 140 kg) Pacemaker or other electronic in-operated devices Non-MR compatible metallic devices Malignant testicular tumors suspected at clinical examination or ultrasound Infectious testicular diseases
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 |
|---|---|---|
| PET/MRIPET/MRI scan | Diagnostic test | PET/MRI |
Primary outcome
SUVmax (maximum standardized uptake value)
Time frame: 1 year
The SUV is the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.
Testicular metabolite concentrations measured by MRI spectroscopy.
Time frame: 1 year
MR spectroscopy is a non-invasive, ionizing-radiation-free analytical technique that has been used to study metabolic changes in different tissues. The unit is p.p.m.
Testicular apparent diffusion coefficient
Time frame: 1 year
Diffusion-weighted magnetic resonance imaging (DW MRI) provides image contrast that is dependent on the random microscopic motion of water protons, which may be substantially altered by different pathological process.
Results and safety
The study was stopped early (reason given: Insufficient inclusion of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No. The results will be published in international journals
Related trials for Fertility Disorders
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Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
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Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
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Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
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.
Louise Risør principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI in people with Fertility Disorders, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 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: stopped early, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 was stopped early (reason given: Insufficient inclusion of patients). Results are not available in the source record.
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?
SUVmax (maximum standardized uptake value) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 4 Nov 2022.