Trial record 14 of 71 for:    Open Studies | "Fertility"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02043444
First received: December 13, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention
Fertility
Radiation: FDG PET-CT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • measure of standardized uptake value (SUV) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comparison between functional volume with PET exam and volume obtained by scrotal echography [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • comparison functional volume with FSH and inhibin [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: secretory azoospermia
110 men with secretory azoospermia
Radiation: FDG PET-CT
Active Comparator: excretory azoospermia
30 men with secretory azoospermia
Radiation: FDG PET-CT
Placebo Comparator: normospermia
20 men with secretory azoospermia
Radiation: FDG PET-CT

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

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043444

Contacts
Contact: Eric HUYGHE, MD 0033561771041 huyghe.e@chu-toulouse.fr
Contact: Patrice NJOMNANG, PhD 0033561771041

Locations
France
UHBordeaux Not yet recruiting
Bordeaux, France, 33076
Contact: Henri CLERMONT GALLERANDE, MD    0033556795540    henri.de-clermont-gallerande@chu-bordeaux.fr   
Principal Investigator: Henri CLERMONT GALLERANDE, MD         
University Hospital Recruiting
Lille, France, 59037
Contact: Jean Marc RIGOT, MD    0033320446793    jean.marc.rigot@chru-lille.fr   
Principal Investigator: Jean Marc RIGOT, MD         
University Hospital Not yet recruiting
Rouen, France, 76031
Contact: Louis SIBERT, MD    0033232888173    louis.sibert@chu-rouen.fr   
Principal Investigator: Louis SIBERT, MD         
UHToulouse Recruiting
Toulouse, France, 31059
Contact: Eric HUYGHE, MD    0033561771041    huyghe.e@chu-toulouse.fr   
Contact: Patrice NJOMNANG, PhD    0033561771041      
Principal Investigator: Eric HUYGHE, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Eric HUYGHE, MD University Hospital, Toulouse
  More Information

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02043444     History of Changes
Other Study ID Numbers: 12 555 01, PHRC 2012
Study First Received: December 13, 2013
Last Updated: July 8, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Azoospermia
Infertility, Male
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 24, 2014