Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-02-17 @ 11:09 PM
Study NCT ID:
NCT03250195
Status:
TERMINATED
Last Update Posted:
2022-11-04
First Post:
2017-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient inclusion of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: