- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415928
Inhibin B/FSH Ratio as a Predictor of Testicular Pathology in NOA
The Predictive Value of Serum Inhibin B/FSH Ratio in Estimating Pathology Results in Patients Undergoing Micro-TESE Due to Azoospermia
Study Overview
Status
Detailed Description
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.
This study aimed to clarify whether the INHB/FSH ratio could serve as a clinically useful marker for estimating testicular pathology severity in men with NOA undergoing micro-TESE.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Elâzığ, Turkey (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:• Obstructive azoospermia
- Incomplete clinical, hormonal, or histopathological data
- Previous testicular malignancy
- History of chemotherapy or radiotherapy affecting spermatogenesis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Early Maturation Arrest (EMA)
Patients diagnosed with early maturation arrest based on testicular histopathological evaluation.
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Late Maturation Arrest (LMA)
Patients diagnosed with late maturation arrest according to histopathological findings.
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Hypospermatogenesis (HS)
Patients with histopathologically confirmed hypospermatogenesis.
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Normospermatogenesis (NS)
Patients with normal spermatogenesis on histopathological examination.
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Sertoli Cell-Only Syndrome (SCOS)
Patients diagnosed with Sertoli cell-only syndrome based on testicular biopsy findings.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Micro-TESE Sperm Retrieval Outcome
Time Frame: During micro-TESE procedure (intraoperative assessment)
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Successful sperm retrieval defined as the presence of spermatozoa on microscopic examination, and its association with histopathological classification and serum hormone levels.
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During micro-TESE procedure (intraoperative assessment)
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Collaborators and Investigators
Investigators
- Principal Investigator: Sezai Oğraş, Elazığ Fethi Sekin City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/12-24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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