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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02043444
Other study ID # 12 555 01
Secondary ID PHRC 2012
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date December 2019

Study information

Verified date November 2020
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 2019
Est. primary completion date June 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Radiation:
FDG PET-CT


Locations

Country Name City State
France UHBordeaux Bordeaux
France University Hospital Lille
France Centre européen Georges Pompidou Paris
France University Hospital Rouen
France UHToulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other comparison functional volume with FSH and inhibin 1 month
Primary measure of standardized uptake value (SUV) 1 month
Secondary comparison between functional volume with PET exam and volume obtained by scrotal echography 1 month
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