Secretory Azoospermia and FDG (Fluoro Deoxyglucose) PET-CT

Fertility Clinical Trial

— AzoPredHisto  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Azoospermia
• Fertility

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