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临床试验/NCT04308486
NCT04308486Unknown不适用

Anti-mullerian Hormone,Testesterone,Esrtadiol,Testesterone/Esrtadiol Ratio as Predictive Values for TESA and TESE Outcome in Non Obstructive Azoospermia

Assiut University0 个研究点目标入组 50 人开始时间: 2020年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Evaluate the predictive value of Anti-mullerian hormone,Testosterone,Estradiol,Testosterone/Estradiol ratio for TESA and TESE outcome in non obstructive azoospermia

研究概览

简要总结

*Evaluate the predictive value of AMH, Testosterone,Estradiol,Testosterone Estradiol ratio for TESA and TESE outcome in non obstructive azoospermic patients.

详细描述

  • The relevance of male infertility has progressively grown , with significant medical, psychological, and socio-economic implications. .. With no sperm found at multiple semen analyses, non-obstructive azoospermia (NOA) is the most severe form of infertility.
  • The introduction to clinical practice of assisted reproduction techniques such as intra-cytoplasmic sperm injection (ICSI) made fatherhood possible for men with (NOA). The extraction of sperm from the testis through testicular sperm aspiration (TESA), testicular sperm extraction (TESE) or open biopsy can result in a favorable reproductive outcome. Nevertheless, all these procedures are invasive in nature with variable possibility of successful sperm extraction. As a consequence, a non-invasive test that could predict the presence of sperm in men with NOA would be of profound clinical importance
  • However, the lack of useful predictive biomarkers suggestive for successful sperm retrieval at microTESE and TESA in NOA men still represents a relevant gap with a very negative return for the patient. Indeed, no significant association has been found between microTESEand TESA sperm retrieval outcomes and preoperative testicular volume, baseline follicular stimulating hormone (FSH) levels, basal level of Testosterone (T) or increased T level following treatments with aromatase inhibitors, clomiphene citrate or human chorionic gonadotropin.
  • Therefore, it has been amust to identify novel and user-friendly prognostic factors reliably predicting surgical outcomes in NOA men in the real-life setting. Among other variables, some hormons can be subjected to studies for this purpose such as levels of testis-derived hormones (which might be representative of the primary testicular failure) as the Anti-Müllerian Hormone (AMH),( which is suggestive for a Sertoli cells' immature phenotype),and testosterone of biological relevance...
  • An investigation from the early 1970s demonstrated that the human testis does indeed secrete estradiol within the spermatic vein, at amean concentration that is 50 times greater than that inthe peripheral plasma . These findings led to the hypothesis that local estrogen levels might be associated with the current stateof spermatogenesis, or the total number of spermatogenic cells in the testis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • a clinical diagnosis of NOA associated with primary couple's infertility;
  • age from 20 to 50 years old
  • freedom from any known systemic diseases affecting the previous hormonal levels such as liver cirrhosis .
  • hormonal therapy for at least two weeks prior to the surgery

排除标准

  • obstructive azoospermia
  • congenital bilateral absent vas

结局指标

主要结局

Evaluate the predictive value of Anti-mullerian hormone,Testosterone,Estradiol,Testosterone/Estradiol ratio for TESA and TESE outcome in non obstructive azoospermia

时间窗: baseline

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

Reham Ahmed Ashraf Fakhr Eldeen Hamoda

Doctor

Assiut University

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