Azoospermia, NonobstructiveNCT07415928
Inhibin B/FSH Ratio as a Predictor of Testicular Pathology in NOA
An observational study of Azoospermia, Nonobstructive and Non-obstructive Azoospermia, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Azoospermia, Nonobstructive, Non-obstructive Azoospermia
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2026to 5 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Incomplete clinical, hormonal, or histopathological data
- Previous testicular malignancy
- History of chemotherapy or radiotherapy affecting spermatogenesis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, 23100
About this study
Official title: The Predictive Value of Serum Inhibin B/FSH Ratio in Estimating Pathology Results in Patients Undergoing Micro-TESE Due to Azoospermia
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.
Read the 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.
- Medical subject headings
- Azoospermia, Nonobstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During micro-TESE procedure (intraoperative assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start10 Jan 2026
- Primary completion2 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azoospermia, NonobstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Bayındır, Elazıg Fethi Sekin Sehir Hastanesi
- Investigators
- Sezai Oğraş, Principal investigator, Elazığ Fethi Sekin City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415928
- Sponsor's protocol ID
- 2025/12-24
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Serum Inhibin B/FSH Ratio in Estimating Pathology Results in Patients Undergoing Micro-TESE Due to Azoospermia
- ClinicalTrials.gov ID
- NCT07415928
- Acronym / sponsor ID
- 2025/12-24
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Incomplete clinical, hormonal, or histopathological data
- Previous testicular malignancy
- History of chemotherapy or radiotherapy affecting spermatogenesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Micro-TESE Sperm Retrieval Outcome
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sezai Oğraş principal investigator
Elazığ Fethi Sekin City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Azoospermia, Nonobstructive and Non-obstructive Azoospermia, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micro-TESE Sperm Retrieval Outcome (time frame: During micro-TESE procedure (intraoperative assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.