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

6 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

60

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: dr. Dyandra Parikesit, BMedSc, Sp.U, FICS
  • Telefoonnummer: +62 813-1971-7571
  • E-mail: dyandrap@gmail.com

Studie Locaties

  • Indonesië
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesië
      • Jakarta, DKI Jakarta, Indonesië
        • Werving
        • Dr. Cipto Mangunkusumo National Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: OTHER
  • Tijdsperspectieven: CROSS_SECTIONAL

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in Testicular FGF2 Gene Expression Between Positive and Negative Sperm Retrieval Groups
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Correlation Between Testicular FGF2 Gene Expression and Serum Reproductive Hormone Levels
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dyandra Parikesit

Onderzoekers

  • Hoofdonderzoeker: dr. Dyandra Parikesit, BMedSc, Sp.U, FICS, Fakultas Kedokteran Universitas Indonesia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 mei 2026

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

22 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 26020289

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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