跳至主要内容
临床试验/NCT07415928
NCT07415928已完成不适用

The Predictive Value of Serum Inhibin B/FSH Ratio in Estimating Pathology Results in Patients Undergoing Micro-TESE Due to Azoospermia

Elazıg Fethi Sekin Sehir Hastanesi1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2026年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
Micro-TESE Sperm Retrieval Outcome

研究概览

简要总结

This retrospective observational study evaluated the diagnostic and predictive value of serum Inhibin B (INHB), follicle-stimulating hormone (FSH), and the INHB/FSH ratio in differentiating histopathological subtypes of non-obstructive azoospermia (NOA) in men undergoing microdissection testicular sperm extraction (micro-TESE). Seventy-three patients treated at a single tertiary referral center between January 2023 and September 2025 were included. Hormonal parameters were assessed preoperatively, and histopathological findings were categorized into five groups (SCOS, EMA, LMA, HSG, NS). The INHB/FSH ratio demonstrated significant discriminative ability across histopathological patterns and showed strong predictive performance in ROC and regression analyses. These findings suggest that the INHB/FSH ratio may serve as a practical, non-invasive biomarker for estimating testicular pathology severity in NOA patients.

详细描述

Non-obstructive azoospermia (NOA) represents a severe form of male infertility characterized by impaired spermatogenesis. Although microdissection testicular sperm extraction (micro-TESE) remains the gold standard for sperm retrieval in these patients, predicting underlying histopathology before surgery remains clinically challenging. Identifying reliable non-invasive biomarkers may improve patient counseling and optimize surgical decision-making.

This retrospective observational study was conducted at Elazığ Fethi Sekin City Hospital, Türkiye. Medical records of men diagnosed with NOA who underwent micro-TESE between January 2023 and September 2025 were reviewed. Patients with obstructive azoospermia, known endocrine disorders, or incomplete clinical data were excluded.

Preoperative serum levels of FSH, luteinizing hormone (LH), total testosterone, and Inhibin B were measured within three months prior to surgery using standardized immunoassay methods. The INHB/FSH ratio was calculated for each patient.

Histopathological evaluation of testicular tissue samples obtained during micro-TESE was performed by an experienced pathologist blinded to hormonal results. Patients were categorized into five histopathological groups: Sertoli Cell-Only Syndrome (SCOS), Early Maturation Arrest (EMA), Late Maturation Arrest (LMA), Hypospermatogenesis (HSG), and Normal Spermatogenesis (NS).

The primary outcome measure was the association between the INHB/FSH ratio and histopathological classification. Statistical analyses included descriptive statistics, non-parametric group comparisons, receiver operating characteristic (ROC) curve analysis to determine discriminative performance, and multivariable regression models to evaluate predictive relationships.

研究设计

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

入排标准

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

入选标准

  • Male patients who underwent micro-TESE for non-obstructive azoospermia
  • Available histopathological evaluation of testicular tissue
  • Available preoperative serum hormone measurements (FSH, LH, testosterone, Inhibin B)

排除标准

  • Obstructive azoospermia
  • Incomplete clinical, hormonal, or histopathological data
  • Previous testicular malignancy
  • History of chemotherapy or radiotherapy affecting spermatogenesis

研究组 & 干预措施

Late Maturation Arrest (LMA)

Patients diagnosed with late maturation arrest according to histopathological findings.

Hypospermatogenesis (HS)

Patients with histopathologically confirmed hypospermatogenesis.

Early Maturation Arrest (EMA)

Patients diagnosed with early maturation arrest based on testicular histopathological evaluation.

Normospermatogenesis (NS)

Patients with normal spermatogenesis on histopathological examination.

Sertoli Cell-Only Syndrome (SCOS)

Patients diagnosed with Sertoli cell-only syndrome based on testicular biopsy findings.

结局指标

主要结局

Micro-TESE Sperm Retrieval Outcome

时间窗: During micro-TESE procedure (intraoperative assessment)

Successful sperm retrieval defined as the presence of spermatozoa on microscopic examination, and its association with histopathological classification and serum hormone levels.

次要结局

未报告次要终点

研究者

发起方
Elazıg Fethi Sekin Sehir Hastanesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serpil Bayındır

Specialist Physician

Elazıg Fethi Sekin Sehir Hastanesi

研究点 (1)

Loading locations...

相似试验