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临床试验/NCT06396117
NCT06396117已完成不适用

Relationship Between Anogenital Distance and Serum AMH and mTESE Associated With or Without Klinefelter Syndrome

Cairo University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年3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
56
试验地点
1
主要终点
Relation of AGD of males with azoospermia (with or without KS) to mTESE outcome

研究概览

简要总结

Azoospermia, the absence of sperm in the ejaculate, affects approximately 1% of males and 15% of infertile men. Non-obstructive azoospermia (NOA) accounts for 60% of azoospermic patients, who rely solely on testicular sperm extraction (TESE) surgery for sperm harvesting. While conventional TESE (cTESE) and microdissection TESE (mTESE) are preferred methods, the lack of predictive biomarkers for successful sperm retrieval (SR) renders treatment unnecessary for many NOA males. However, research suggests that anti-Mullerian hormone (AMH) and anogenital distance (AGD) may serve as predictors of positive SR at mTESE in NOA males. AGD, a marker of fetal androgen disruption and adult outcomes, may also assess male reproductive potential by predicting normal genital growth and sperm creation. A cross-sectional study found a positive correlation between AGD and total sperm count, concentration, and motility in infertile men aged 25-38, providing valuable prognostic insights for azoospermic men.

详细描述

Azoospermia, which is defined as the lack of spermatozoa in the ejaculate, is a condition that affects around one percent of males and fifteen percent of men who are infertile. Sixty percent of azoospermic patients are affected by non-obstructive azoospermia, often known as NOA.

To harvest sperm for assisted reproductive technology (ART), this subset of men has no other choice except to undergo testicular sperm extraction (TESE) surgery.

Conventional TESE (cTESE) and microdissection TESE (mTESE) are the most preferred procedures in terms of sperm retrieval (SR) rates and the decrease of damage caused by excision. Studies have revealed varying percentages of positive SR, ranging from thirty percent to sixty percent.

This treatment is not necessary for a significant number of NOA boys because there are no biomarkers or procedures that are clinically acceptable that can predict a positive SR score at mTESE.

According to earlier research, anti-mullerian hormone (AMH), which is a homodimeric glycoprotein belonging to the family of transforming growth factor-b, has the potential to predict either a positive or negative significant difference (SR) at mTESE in iNOA. Throughout the course of development, Sertoli cells (SCs) secrete Amyloid-beta (AMH) in order to regress the Mullerian ducts and ensure that male sex differentiation occurs. AMH levels drop significantly when the development of puberty in males and the maturation of SCs occurs. It has been suggested that this hormone, which is solely produced by spermatocytes in males, can be used as an indirect marker of spermatogenesis, maturation of spermatocytes, and immaturity of the prepubertal testes.

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 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • All NOA patients underwent mTESE at the Andrology department, Kasr Al-Ainy hospitals

排除标准

  • patients with
  • Obstructive azoospermia
  • Retrograde Ejaculation
  • Men with hypogonadotropic hypogonadism

结局指标

主要结局

Relation of AGD of males with azoospermia (with or without KS) to mTESE outcome

时间窗: 1 months

Higher AGD might be correlated to higher sperm retrieval

Relation of AMH in males with azoospermia (with or without KS) to mTESE outcome

时间窗: 1 month

Higher AMH might be correlated to higher sperm retrieval

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

Lecturer

Cairo University

研究点 (1)

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