NCT07415928

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

23 days

First QC Date

February 10, 2026

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Micro-TESE Sperm Retrieval Outcome

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

    During micro-TESE procedure (intraoperative assessment)

Study Arms (5)

Early Maturation Arrest (EMA)

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

Late Maturation Arrest (LMA)

Patients diagnosed with late maturation arrest according to histopathological findings.

Hypospermatogenesis (HS)

Patients with histopathologically confirmed hypospermatogenesis.

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.

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult male patients diagnosed with non-obstructive azoospermia who underwent micro-TESE at a tertiary referral center and had available histopathological and hormonal evaluation data.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Azoospermia, Nonobstructive

Study Officials

  • Sezai Oğraş

    Elazığ Fethi Sekin City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physician

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 17, 2026

Study Start

January 10, 2026

Primary Completion

February 2, 2026

Study Completion

February 5, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations