Secretory Azoospermia and FDG (Fluoro Deoxyglucose) PET-CT (AzoPredHisto)
Primary Purpose
Fertility
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FDG PET-CT
Sponsored by
About this trial
This is an interventional other trial for Fertility
Eligibility Criteria
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
Sites / Locations
- UHBordeaux
- University Hospital
- Centre européen Georges Pompidou
- University Hospital
- UHToulouse
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
secretory azoospermia
excretory azoospermia
normospermia
Arm Description
110 men with secretory azoospermia will have FDG PET-CT
30 men with secretory azoospermia will have FDG PET-CT
20 men with secretory azoospermia will have FDG PET-CT
Outcomes
Primary Outcome Measures
measure of standardized uptake value (SUV)
Secondary Outcome Measures
comparison between functional volume with PET exam and volume obtained by scrotal echography
Full Information
NCT ID
NCT02043444
First Posted
December 13, 2013
Last Updated
November 9, 2020
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02043444
Brief Title
Secretory Azoospermia and FDG (Fluoro Deoxyglucose) PET-CT
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
secretory azoospermia
Arm Type
Experimental
Arm Description
110 men with secretory azoospermia will have FDG PET-CT
Arm Title
excretory azoospermia
Arm Type
Active Comparator
Arm Description
30 men with secretory azoospermia will have FDG PET-CT
Arm Title
normospermia
Arm Type
Placebo Comparator
Arm Description
20 men with secretory azoospermia will have FDG PET-CT
Intervention Type
Radiation
Intervention Name(s)
FDG PET-CT
Primary Outcome Measure Information:
Title
measure of standardized uptake value (SUV)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
comparison between functional volume with PET exam and volume obtained by scrotal echography
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
comparison functional volume with FSH and inhibin
Time Frame
1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric HUYGHE, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHBordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
University Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
UHToulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24180380
Citation
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.
Results Reference
background
Learn more about this trial
Secretory Azoospermia and FDG (Fluoro Deoxyglucose) PET-CT
We'll reach out to this number within 24 hrs