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

Fertility Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03250195
• Other study ID #: H-17013319
• Status: Terminated
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: August 7, 2021

Study information

• Verified date: November 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 7, 2021
• Est. primary completion date: August 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders
• Infertility
• Infertility, Male

Intervention

Diagnostic Test:
• PET/MRI
PET/MRI scan

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Østerbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year