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临床试验/NCT04397887
NCT04397887已完成不适用

Seminal TEX101 as a Predictor of Recovery of Spermatogenesis in Azoospermic Men With Palpable Varicocele

Cairo University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Sperm retrieval in ejaculate

研究概览

简要总结

The aim of the study is to assess if seminal TEX 101 can predict the restoration of spermatogenesis and appearance of sperms in the ejaculate after micro-surgical varicocelectomy among azoospermic patients.

详细描述

Male patients (40) cases attending the outpatient clinic of Andrology at KASR EL-AINI university hospitals, all patients presented with azoospermia, age:18-43 years, complaining mainly of infertility or accidently discovered azoospermia during premarital check-up or chronic testicular pain caused by longstanding varicocele. Infertile Non Obstructive Azoospermia (NOA) (n=40) subjected to varicocelectomy and patients evaluated 3 months after varicocelectomy by semen analysis, then according to results population divided into 2 groups: Group A (Responders): Patients with positive semen analysis for

sperms 3 months after varicocelectomy.

Group B (Non Responders): Patients with no sperms in semen analysis

in 3 and/or 6 months after varicocelectomy.

Method of Estimation of human TEX101 in semen:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Azoospermia in at least 2 separate semen analyses
  • Palpable varicocele

排除标准

  • Obstructive azoospermia
  • Abnormal Karyotype
  • Previous chemotherapy, radiotherapy and or diagnosed maligancy.
  • previous testicular of inguinal surgeries.
  • secondary azoospermia

结局指标

主要结局

Sperm retrieval in ejaculate

时间窗: 6 months follow-up

finding sperms in the ejaculate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Wael Ragab

Andrology consultant/ lecturer

Cairo University

研究点 (2)

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