Secretory Azoospermia and FDG (Fluoro Deoxyglucose) PET-CT

Not Applicable

Completed

• Conditions: Fertility
• Interventions: Radiation: FDG PET-CT

• Registration Number: NCT02043444
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-12-13
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2019-06
• Study Completion: 2019-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normospermia	FDG PET-CT	20 men with secretory azoospermia will have FDG PET-CT
secretory azoospermia	FDG PET-CT	110 men with secretory azoospermia will have FDG PET-CT
excretory azoospermia	FDG PET-CT	30 men with secretory azoospermia will have FDG PET-CT

Primary Outcome Measures

Name	Time	Method
measure of standardized uptake value (SUV)	1 month

Secondary Outcome Measures

Name	Time	Method
comparison between functional volume with PET exam and volume obtained by scrotal echography	1 month

Trial Locations

Locations (4)

University Hospital; 🇫🇷 Rouen, France

UHBordeaux; 🇫🇷 Bordeaux, France

Centre européen Georges Pompidou; 🇫🇷 Paris, France

UHToulouse; 🇫🇷 Toulouse, France