Secretory Azoospermia and FDG (Fluoro Deoxyglucose) PET-CT (AzoPredHisto)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02043444
Recruitment Status : Recruiting
First Posted : January 23, 2014
Last Update Posted : November 27, 2017
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Compare FDG PET-CT parameters between azoospermia patients having an extraction of sperm cells by positive testicular extraction and those with a negative extraction.

Condition or disease Intervention/treatment Phase
Fertility Radiation: FDG PET-CT Not Applicable

Detailed Description:
One third of infertilities is of exclusive male origin and one third of mixed origin (presence of a male factor). Ten percent of infertile male have azoospermia with a secretory origin in most of cases. Surgical extraction of spermatozoa from testicle is the unique possibility to increase the chance for these men to have children using in vitro fecundation. However, surgical extraction of spermatozoa is successful in 50% of these patients. To date, none of the methods for exploration of male fertility (spermogram, hormonal investigation - with dosage of FSH (follicle stimulating hormone) and inhibin B - and scrotal ultrasound) can predict the success of surgical sperm cells extraction. We also miss the prognostic markers of the testicular function recovery after sterilizing treatments (chemotherapy, radiotherapy). The presence of GLUT3 (glucose) transporters, which are responsible for the fluoro deoxyglucose uptake, has been reported in seminiferous tubules. We have previously shown in a pilot study on a population of men without testis cancer that FDG PET-CT parameters - including the standardized uptake value mean, the standardized uptake value max, and the functional testicular volume - were correlated with the parameters of spermogram (sperm count, motility, vitality). These findings open the way to investigations on the role of the FDG PET-CT in evaluation of secretory azoospermia.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of FDG PET-CT Estimated Testis Functional Value Between Patients Having Positive Testicular Sperm Cells Extraction and Patients With a Negative Extraction, in Men With Azoospermia
Actual Study Start Date : January 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: secretory azoospermia
110 men with secretory azoospermia will have FDG PET-CT
Radiation: FDG PET-CT
Active Comparator: excretory azoospermia
30 men with secretory azoospermia will have FDG PET-CT
Radiation: FDG PET-CT
Placebo Comparator: normospermia
20 men with secretory azoospermia will have FDG PET-CT
Radiation: FDG PET-CT

Primary Outcome Measures :
  1. measure of standardized uptake value (SUV) [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. comparison between functional volume with PET exam and volume obtained by scrotal echography [ Time Frame: 1 month ]

Other Outcome Measures:
  1. comparison functional volume with FSH and inhibin [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

absence of sperm cells on 2 spermograms in 3 months interval testicular size has to be determined in order to categorized in a group to accept surgery-

Exclusion Criteria:

allergy to fluoro deoxyglucose clinical varicocele

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02043444

Contact: Eric HUYGHE, MD 0033561771041
Contact: Thierry ALMONT, PhD 0033561771041

UHBordeaux Recruiting
Bordeaux, France, 33076
Contact: Henri CLERMONT GALLERANDE, MD    0033556795540   
Principal Investigator: Henri CLERMONT GALLERANDE, MD         
University Hospital Recruiting
Lille, France, 59037
Contact: Jean Marc RIGOT, MD    0033320446793   
Principal Investigator: Jean Marc RIGOT, MD         
Centre européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Nicolas THIOUNN, MD         
University Hospital Recruiting
Rouen, France, 76031
Contact: Louis SIBERT, MD    0033232888173   
Principal Investigator: Louis SIBERT, MD         
UHToulouse Recruiting
Toulouse, France, 31059
Contact: Eric HUYGHE, MD    0033561771041   
Contact: Patrice NJOMNANG, PhD    0033561771041      
Principal Investigator: Eric HUYGHE, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: Eric HUYGHE, MD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse Identifier: NCT02043444     History of Changes
Other Study ID Numbers: 12 555 01
PHRC 2012 ( Other Grant/Funding Number: PHRC )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility, Male
Genital Diseases, Male