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

NCT ID: NCT03250195

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2021-08-07

Brief Summary

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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

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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

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Fertility Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET/MRI

All participants will have a PET/MRI performed

Group Type OTHER

PET/MRI

Intervention Type DIAGNOSTIC_TEST

PET/MRI scan

Interventions

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PET/MRI

PET/MRI scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Louise Madeleine Risør

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise Risør

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, Østerbro, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-17013319

Identifier Type: -

Identifier Source: org_study_id

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