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

Toulouse University Hospital

Status: Completed

Conditions: Fertility

Treatments: Radiation: FDG PET-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02043444

PHRC 2012 (Other Grant/Funding Number)

12 555 01

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups, including a placebo group

secretory azoospermia

Experimental group

Description:

110 men with secretory azoospermia will have FDG PET-CT

Treatment:

Radiation: FDG PET-CT

excretory azoospermia

Active Comparator group

Description:

30 men with secretory azoospermia will have FDG PET-CT

Treatment:

Radiation: FDG PET-CT

normospermia

Placebo Comparator group

Description:

20 men with secretory azoospermia will have FDG PET-CT

Treatment:

Radiation: FDG PET-CT