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

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

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

Study Overview

• Status: Completed
• Conditions: Fertility
• Intervention / Treatment: Radiation: FDG PET-CT

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
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • UHBordeaux
  • Lille, France, 59037
    • University Hospital
  • Paris, France, 75015
    • Centre européen Georges Pompidou
  • Rouen, France, 76031
    • University Hospital
  • Toulouse, France, 31059
    • UHToulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
measure of standardized uptake value (SUV)	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
comparison between functional volume with PET exam and volume obtained by scrotal echography	1 month

Other Outcome Measures

Outcome Measure	Time Frame
comparison functional volume with FSH and inhibin	1 month

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Publications and helpful links

General Publications

• Ferretti L, Sargos P, Gross-Goupil M, Izard V, Wallerand H, Huyghe E, Rigot JM, Durand X, Benoit G, Ferriere JM, Droupy S. Testicular-sparing surgery for bilateral or monorchide testicular tumours: a multicenter study of long-term oncological and functional results. BJU Int. 2014 Dec;114(6):860-4. doi: 10.1111/bju.12549. Epub 2014 Aug 16.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: December 13, 2013
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Azoospermia
• Other Study ID Numbers: 12 555 01; PHRC 2012 (Other Grant/Funding Number: PHRC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No