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Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)

Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03250195
Enrollment
12
Registered
2017-08-15
Start date
2017-08-07
Completion date
2021-08-07
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility Disorders

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTPET/MRI

PET/MRI scan

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
SUVmax (maximum standardized uptake value)1 yearThe 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.1 yearMR 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 coefficient1 yearDiffusion-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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026