Differences in FGF2 Levels by Sperm Retrieval Success in Non-Obstructive Azoospermia
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:
- Does FGF2 expression differ between participants with and without successful sperm retrieval?
- Is FGF2 expression associated with lower levels of follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) in the blood?
- 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?
- Is FGF2 expression associated with OCT4 and VASA, markers found in cells involved in sperm production?
- 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:
- Collect clinical information and review blood hormone test results.
- Measure testicular volume and examine testicular tissue to assess sperm development.
- 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).
- Examine testicular tissue under a microscope to determine whether sperm are found.
- 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: dr. Dyandra Parikesit, BMedSc, Sp.U, FICS
- Número de teléfono: +62 813-1971-7571
- Correo electrónico: dyandrap@gmail.com
Ubicaciones de estudio
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia
- Reclutamiento
- Bunda Hospital Menteng
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Contacto:
- dr. Florencia Irena
- Número de teléfono: +6281261788510
- Correo electrónico: florenciairenawdj@gmail.com
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Jakarta, DKI Jakarta, Indonesia
- Reclutamiento
- Dr. Cipto Mangunkusumo National Hospital
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Contacto:
- dr. Florencia Irena
- Número de teléfono: +6281261788510
- Correo electrónico: florenciairenawdj@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
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Positive Sperm Retrieval
Men with non-obstructive azoospermia (NOA) who undergo microdissection testicular sperm extraction (mTESE) with successful sperm retrieval. |
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Negative Sperm Retrieval
Men with non-obstructive azoospermia (NOA) who undergo microdissection testicular sperm extraction (mTESE) without successful sperm retrieval. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in Testicular FGF2 Gene Expression Between Positive and Negative Sperm Retrieval Groups
Periodo de tiempo: Postoperative (FGF2 gene expression assessment), through study completion, an average of 1 year
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation Between Testicular FGF2 Gene Expression and Serum Reproductive Hormone Levels
Periodo de tiempo: Baseline (serum reproductive hormone assessment) and postoperative (FGF2 gene expression assessment), through study completion, an average of 1 year
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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
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Correlation Between Testicular FGF2 Gene Expression, Testicular Volume, and Modified Johnsen Score
Periodo de tiempo: Baseline (testicular volume assessment) and postoperative (FGF2 gene expression and histopathological assessments), through study completion, an average of 1 year
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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
|
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Correlation Between Testicular FGF2 Gene Expression and OCT4 and VASA Gene Expression
Periodo de tiempo: Postoperative (FGF2, OCT4, and VASA gene expression assessments), through study completion, an average of 1 year
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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
|
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Testicular FGF2 Gene Expression as an Independent Predictor of Successful Sperm Retrieval During mTESE
Periodo de tiempo: Perioperative (sperm retrieval outcome assessment) and postoperative (FGF2 gene expression assessment), through study completion, an average of 1 year
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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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: dr. Dyandra Parikesit, BMedSc, Sp.U, FICS, Fakultas Kedokteran Universitas Indonesia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 26020289
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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