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

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Completed
• CT.gov ID: NCT02043444
• Collaborator: (none)
• Enrollment: 160
• Locations: 5
• Arms: 3
• Actual Duration (Months): 71
• Patients Per Site: 32
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fertility	Radiation: FDG PET-CT	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: secretory azoospermia 110 men with secretory azoospermia will have FDG PET-CT	Radiation: FDG PET-CT
Active Comparator: excretory azoospermia 30 men with secretory azoospermia will have FDG PET-CT	Radiation: FDG PET-CT
Placebo Comparator: normospermia 20 men with secretory azoospermia will have FDG PET-CT	Radiation: FDG PET-CT

Outcome Measures

Primary Outcome Measures

1. measure of standardized uptake value (SUV) [1 month]

Secondary Outcome Measures

1. comparison between functional volume with PET exam and volume obtained by scrotal echography [1 month]

Other Outcome Measures

1. comparison functional volume with FSH and inhibin [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UHBordeaux	Bordeaux		France	33076
2	University Hospital	Lille		France	59037
3	Centre européen Georges Pompidou	Paris		France	75015
4	University Hospital	Rouen		France	76031
5	UHToulouse	Toulouse		France	31059

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

• Principal Investigator: Eric HUYGHE, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT02043444
• Other Study ID Numbers: 12 555 01; PHRC 2012
• First Posted: Jan 23, 2014
• Last Update Posted: Nov 10, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Azoospermia

Study Results

No Results Posted as of Nov 10, 2020