NCT02043444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 6, 2026

Status Verified

November 1, 2020

Enrollment Period

5.4 years

First QC Date

December 13, 2013

Last Update Submit

January 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • measure of standardized uptake value (SUV)

    1 month

Secondary Outcomes (1)

  • comparison between functional volume with PET exam and volume obtained by scrotal echography

    1 month

Other Outcomes (1)

  • comparison functional volume with FSH and inhibin

    1 month

Study Arms (3)

secretory azoospermia

EXPERIMENTAL

110 men with secretory azoospermia will have FDG PET-CT

Radiation: FDG PET-CT

excretory azoospermia

ACTIVE COMPARATOR

30 men with secretory azoospermia will have FDG PET-CT

Radiation: FDG PET-CT

normospermia

PLACEBO COMPARATOR

20 men with secretory azoospermia will have FDG PET-CT

Radiation: FDG PET-CT

Interventions

FDG PET-CTRADIATION
excretory azoospermianormospermiasecretory azoospermia

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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-

You may not qualify if:

  • allergy to fluoro deoxyglucose clinical varicocele

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UHBordeaux

Bordeaux, 33076, France

Location

University Hospital

Lille, 59037, France

Location

Centre européen Georges Pompidou

Paris, 75015, France

Location

University Hospital

Rouen, 76031, France

Location

UHToulouse

Toulouse, 31059, France

Location

Related Publications (2)

  • 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.

    PMID: 24180380BACKGROUND
  • Dierickx LO, Bettiol C, Huglo D, Marcelli F, Sibert L, Gouel P, Ferretti L, Orlhac F, Huyghe E. Is 18F-fluorodexyglucose testicular uptake using positron emission tomography/computed tomography correlated with the results of a testicular sperm extraction procedure in the case of azoospermia (French prospective multicenter AZOPREDHISTOTEP study)? Eur J Nucl Med Mol Imaging. 2026 Apr;53(5):3283-3290. doi: 10.1007/s00259-025-07583-7. Epub 2025 Nov 21.

Study Officials

  • Eric HUYGHE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2013

First Posted

January 23, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

January 6, 2026

Record last verified: 2020-11

Locations