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临床试验/NCT02043444
NCT02043444已完成不适用

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

University Hospital, Toulouse6 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
6
主要终点
measure of standardized uptake value (SUV)

研究概览

简要总结

Compare FDG PET-CT parameters between azoospermia patients having an extraction of sperm cells by positive testicular extraction and those with a negative extraction.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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-

排除标准

  • allergy to fluoro deoxyglucose clinical varicocele

研究组 & 干预措施

secretory azoospermia

Experimental

110 men with secretory azoospermia will have FDG PET-CT

干预措施: FDG PET-CT (Radiation)

excretory azoospermia

Active Comparator

30 men with secretory azoospermia will have FDG PET-CT

干预措施: FDG PET-CT (Radiation)

normospermia

Placebo Comparator

20 men with secretory azoospermia will have FDG PET-CT

干预措施: FDG PET-CT (Radiation)

结局指标

主要结局

measure of standardized uptake value (SUV)

时间窗: 1 month

次要结局

  • comparison between functional volume with PET exam and volume obtained by scrotal echography(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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