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

6. listopadu 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Typ studie

Pozorovací

Zápis (Odhadovaný)

60

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

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

Studijní místa

  • Indonésie
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonésie
      • Jakarta, DKI Jakarta, Indonésie
        • Nábor
        • Dr. Cipto Mangunkusumo National Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Mužský

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: OTHER
  • Časové perspektivy: CROSS_SECTIONAL

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Difference in Testicular FGF2 Gene Expression Between Positive and Negative Sperm Retrieval Groups
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Correlation Between Testicular FGF2 Gene Expression and Serum Reproductive Hormone Levels
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Dyandra Parikesit

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. května 2026

Primární dokončení (Odhadovaný)

1. května 2027

Dokončení studie (Odhadovaný)

1. května 2027

Termíny zápisu do studia

První předloženo

22. října 2026

První předloženo, které splnilo kritéria kontroly kvality

6. listopadu 2026

První zveřejněno (Aktuální)

13. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

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Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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