Differences in FGF2 Levels by Sperm Retrieval Success in Non-Obstructive Azoospermia

November 6, 2026 updated by: Dyandra Parikesit

Differences in FGF2 Levels in Patients With Non-Obstructive Azoospermia According to Sperm Retrieval Success: Associations With Hormonal Profiles, Semen Parameters, Testicular Histology, and the Germ Cell Biomarkers OCT4 and VASA

The goal of this observational study is to determine whether fibroblast growth factor 2 (FGF2) expression in testicular tissue differs between men with non-obstructive azoospermia (NOA) who have successful and unsuccessful sperm retrieval during microdissection testicular sperm extraction (micro-TESE).

The main questions it aims to answer are:

  1. Does FGF2 expression differ between participants with and without successful sperm retrieval?
  2. Is FGF2 expression associated with lower levels of follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) in the blood?
  3. Is FGF2 expression associated with higher levels of luteinizing hormone (LH) and total testosterone in the blood, larger testicular volume, and higher Johnsen scores, which reflect sperm development in testicular tissue?
  4. Is FGF2 expression associated with OCT4 and VASA, markers found in cells involved in sperm production?
  5. Can FGF2 expression help predict whether sperm retrieval will be successful?

Participants will be adult men with NOA who undergo micro-TESE at the participating hospitals. Researchers will:

  1. Collect clinical information and review blood hormone test results.
  2. Measure testicular volume and examine testicular tissue to assess sperm development.
  3. Analyze testicular tissue obtained during micro-TESE to measure FGF2, OCT4, and VASA gene expression using a laboratory method called quantitative reverse transcription polymerase chain reaction (RT-qPCR).
  4. Examine testicular tissue under a microscope to determine whether sperm are found.
  5. Compare results between participants with and without successful sperm retrieval and assess relationships between FGF2 expression and other clinical, hormonal, and tissue findings.

The findings may improve understanding of sperm production in men with NOA and help researchers investigate whether FGF2 can serve as a marker of sperm retrieval success.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: dr. Dyandra Parikesit, BMedSc, Sp.U, FICS
  • Phone Number: +62 813-1971-7571
  • Email: dyandrap@gmail.com

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia
      • Jakarta, DKI Jakarta, Indonesia
        • Recruiting
        • Dr. Cipto Mangunkusumo National Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Adult men over 18 years of age diagnosed with non-obstructive azoospermia (NOA) who undergo microdissection testicular sperm extraction (mTESE) at Dr. Cipto Mangunkusumo National General Hospital and Bunda Menteng Hospital, Indonesia, and meet the study's inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Adult men (aged over 18 years) diagnosed with primary infertility and non-obstructive azoospermia (NOA), based on medical history, physical examination, and supporting investigations.
  • Completion of all required pre-study examinations.
  • Non-smokers or individuals who have stopped smoking for at least two months.
  • Presence of a Y-chromosome AZFc microdeletion.

Exclusion Criteria:

  • Refusal to participate in the study.
  • Patients with chronic diseases, such as cancer, hepatitis, or autoimmune diseases.
  • Active infection.
  • Patients with physical or mental disabilities.
  • Chromosomal abnormalities, such as Klinefelter syndrome or Y-chromosome microdeletions involving the AZFa or AZFb regions.
  • Adverse effects related to therapy.
  • Obstructive azoospermia.
  • Patients with testicular cancer or cancer involving other genital organs.
  • Patients with abnormalities of the genital tract.
  • History of chemotherapy or radiotherapy.
  • Hypogonadotropic hypogonadism.
  • History of testicular sperm aspiration or other surgical sperm retrieval procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: OTHER
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Positive Sperm Retrieval

Men with non-obstructive azoospermia (NOA) who undergo microdissection testicular sperm extraction (mTESE) with successful sperm retrieval.
Negative Sperm Retrieval

Men with non-obstructive azoospermia (NOA) who undergo microdissection testicular sperm extraction (mTESE) without successful sperm retrieval.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in Testicular FGF2 Gene Expression Between Positive and Negative Sperm Retrieval Groups
Time Frame: Postoperative (FGF2 gene expression assessment), through study completion, an average of 1 year

Testicular fibroblast growth factor 2 (FGF2) gene expression will be measured using reverse transcription quantitative polymerase chain reaction (RT-qPCR) in testicular tissue obtained during microdissection testicular sperm extraction (mTESE). Tissue samples will undergo RNA extraction, complementary DNA (cDNA) synthesis, and subsequent RT-qPCR analysis after collection. Sperm retrieval outcomes will be classified as positive or negative based on microscopic examination of testicular specimens, using the criteria specified in the study protocol. FGF2 gene expression will be compared between the two groups using an independent t-test or Mann-Whitney test, depending on data distribution.
Postoperative (FGF2 gene expression assessment), through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between Testicular FGF2 Gene Expression and Serum Reproductive Hormone Levels
Time Frame: Baseline (serum reproductive hormone assessment) and postoperative (FGF2 gene expression assessment), through study completion, an average of 1 year

The correlations between testicular FGF2 gene expression and serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), total testosterone, and anti-Müllerian hormone (AMH) concentrations will be evaluated. Serum hormone levels will be measured using enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay (CLIA). FSH and LH will be expressed in mIU/mL, while total testosterone and AMH will be expressed in ng/mL. Testicular FGF2 gene expression will be measured using RT-qPCR in tissue collected during mTESE and analyzed after surgery. Pearson or Spearman correlation analysis will be performed depending on data distribution.
Baseline (serum reproductive hormone assessment) and postoperative (FGF2 gene expression assessment), through study completion, an average of 1 year
Correlation Between Testicular FGF2 Gene Expression, Testicular Volume, and Modified Johnsen Score
Time Frame: Baseline (testicular volume assessment) and postoperative (FGF2 gene expression and histopathological assessments), through study completion, an average of 1 year

The correlations between testicular FGF2 gene expression, testicular volume, and Modified Johnsen Score (MJS) will be evaluated. Testicular volume will be measured using a Prader orchidometer or scrotal ultrasonography and expressed in milliliters (mL). Ultrasonographic testicular volume will be calculated using the formula 0.52 × length × width × height. Testicular tissue will be collected during mTESE and subsequently examined using hematoxylin and eosin (H&E) staining. Histopathological assessment will use the Modified Johnsen Scoring system (1-9), with the mean score per testis used for analysis. FGF2 gene expression will be measured using RT-qPCR. Pearson or Spearman correlation analysis will be performed depending on data distribution.
Baseline (testicular volume assessment) and postoperative (FGF2 gene expression and histopathological assessments), through study completion, an average of 1 year
Correlation Between Testicular FGF2 Gene Expression and OCT4 and VASA Gene Expression
Time Frame: Postoperative (FGF2, OCT4, and VASA gene expression assessments), through study completion, an average of 1 year

The correlations between testicular FGF2 gene expression and germ cell biomarkers OCT4 and VASA will be evaluated. Testicular tissue samples will be obtained during mTESE and subsequently processed for RNA extraction, complementary DNA (cDNA) synthesis, and reverse transcription quantitative polymerase chain reaction (RT-qPCR). Relative expression of OCT4 and VASA will be assessed using ΔCt or fold change, as described in the study protocol. Correlations between FGF2 expression and OCT4 and VASA expression will be analyzed using Pearson or Spearman correlation tests according to data distribution.
Postoperative (FGF2, OCT4, and VASA gene expression assessments), through study completion, an average of 1 year
Testicular FGF2 Gene Expression as an Independent Predictor of Successful Sperm Retrieval During mTESE
Time Frame: Perioperative (sperm retrieval outcome assessment) and postoperative (FGF2 gene expression assessment), through study completion, an average of 1 year

Multivariable logistic regression analysis will be performed to evaluate whether testicular FGF2 gene expression is an independent predictor of successful sperm retrieval in patients with non-obstructive azoospermia undergoing mTESE. FGF2 gene expression will be measured using RT-qPCR in testicular tissue collected during mTESE and analyzed after surgery. Sperm retrieval outcomes will be classified as positive or negative based on microscopic examination of testicular specimens, according to the study protocol. The analysis will control for confounding variables. Statistical significance will be defined as p < 0.05, with a 95% confidence interval.
Perioperative (sperm retrieval outcome assessment) and postoperative (FGF2 gene expression assessment), through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dyandra Parikesit

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: dr. Dyandra Parikesit, BMedSc, Sp.U, FICS, Fakultas Kedokteran Universitas Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26020289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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