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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07529288
Valutazione dei Sindromi della Medicina Tradizionale nell'Infertilità Maschile con Oligoastenoteratozoospermia
Caratterizzazione delle Sindromi della Medicina Tradizionale nell'Infertilità Maschile con Oligoasthenoteratozoospermia Tramite Modelli ad Albero Latenti
The goal of this observational study is to identify and evaluate the characteristics of Traditional Medicine (TM) syndromes in men aged 18 to 60 with male infertility and oligoasthenoteratozoospermia (OAT) syndrome. The main questions it aims to answer are:
- What are the common Traditional Medicine syndromes and symptoms associated with male infertility based on Traditional Medicine literature?
- What are the specific Traditional Medicine syndromes and symptoms found in men with OAT syndrome at Binh Dan Hospital when analyzed using Latent Tree Models?
The research will be conducted in two phases:
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Phase 1 (Literature Review): Researchers will collect and analyze Traditional Medicine texts to list the symptoms and syndromes related to male infertility. This phase will help create a standardized clinical survey.
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Phase 2 (Clinical Survey): Researchers will recruit 300 male participants with OAT syndrome.
- Participants will answer a survey questionnaire about their Traditional Medicine symptoms.
- Researchers will apply Latent Tree Models (a mathematical approach) to the collected data to objectively classify the TM syndromes.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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Study Rationale and Methodology Oligoasthenoteratozoospermia (OAT) is a significant contributor to male infertility, characterized by concurrent abnormalities in sperm concentration, motility, and morphology. While Traditional Medicine has been recognized by the World Health Organization (WHO) for its role in improving semen parameters, the classification of TM syndromes often relies on subjective clinical experience. This study utilizes Latent Tree Models (LTMs), a sophisticated probabilistic graphical model, to objectively identify the distribution and characteristics of TM syndromes in men with OAT.
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Phase 1: Literature-Based Framework Development The study begins with a systematic survey of classical and modern TM literature published between July 2025 and October 2025.
- Source Selection: Literature includes classical texts recognized by the WHO/WPRO, textbooks from major medical universities in Vietnam and China, and expert consensus from Traditional Medicine associations.
- Survey Tool Construction: Symptoms and syndromes related to male infertility are extracted and tabulated. Symptoms with a frequency of higher 30% in the literature are selected to build the formal clinical survey questionnaire.
- Standardization: All Traditional Medicine terms are standardized according to WHO international terminologies.
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Phase 2: Clinical Implementation and Data Collection Clinical data will be collected at the Department of Andrology, Binh Dan Hospital, from November 2025 to August 2026.
Clinical Screening: Patients are first diagnosed with OAT by an andrologist based on the WHO Laboratory Manual (6th Edition).
Traditional Examination: Eligible participants undergo a non-invasive TM examination, including the "Four Examinations" (observation, listening/smelling, inquiring, and palpation).
Symptom Mapping: Symptoms are recorded as binary variables (presence or absence) to facilitate mathematical modeling.
*Statistical Analysis Using Latent Tree Models (LTMs) The core analysis employs the Lantern 5.0 software to discover the hidden (latent) structure of TM syndromes.
- Structure Learning: The Extension-Adjustment-Simplify-Transfer (EAST) algorithm is used to automatically group symptoms that frequently co-occur or are mutually exclusive.
- Parameter Estimation: The Expectation-Maximization (EM) algorithm estimates the probability of each patient belonging to a specific latent syndrome class.
- Syndrome Identification: Latent variables are interpreted and named as TM syndromes based on the symptoms that provide at least 95% Cumulative Mutual Information (CMI).
- Classification Algorithm: The study establishes a scoring threshold for each syndrome based on Naïve Bayes principles, allowing for a quantitative diagnosis of TM patterns in the OAT population.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Ho Chi Minh City
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Ho Chi Minh City, Ho Chi Minh City, Vietnam
- Binh Dan Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
The study population is a clinical cohort of men aged 18 to 60 years who seek medical consultation or treatment for reproductive health issues at the Department of Andrology, Binh Dan Hospital, Ho Chi Minh City. The specific population focuses on individuals diagnosed with male infertility and Oligoasthenoteratozoospermia (OAT) syndrome, characterized by a concurrent reduction in sperm count, motility, and normal morphology according to the World Health Organization (WHO) standards .
Descrizione
Inclusion Criteria:
- Male patients aged between 18 and 60 years.
- Diagnosed with male infertility by an andrology specialist according to World Health Organization (WHO) standards.
- Semen analysis results meet the diagnostic criteria for Oligoasthenoteratozoospermia (OAT) syndrome.
- Voluntary agreement to participate in the research and signed Informed Consent Form.
Exclusion Criteria:
- Infertility caused by genetic or chromosomal abnormalities, including but not limited to: Klinefelter syndrome, Sandberg mosaic syndrome (46 XY/47 XXY), or XYY syndrome.
- Presence of structural abnormalities of the reproductive organs.
- Patients with Azoospermia (absence of sperm in the ejaculate) as defined by WHO 2021 standards.
- Use of medications affecting spermatogenesis within the last 3 months, including: cannabinoids, hydantoins, valproate, anabolic steroids, cimetidine, colchicine, spironolactone, nitrofurantoin, sulfasalazine, or calcium channel blockers.
- Inability to understand or answer survey questions due to physical or mental limitations (e.g., mutism, deafness, intellectual disability, coma, or being on a ventilator in the ICU).
- Lack of cooperation during the clinical examination and interview process.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: CASE_ONLY
- Prospettive temporali: CROSS_SECTIONAL
Coorti e interventi
Gruppo / Coorte |
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Male Infertility Patients with OAT Syndrome
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Classification of Traditional Medicine Syndromes
Lasso di tempo: At the time of enrollment in the study
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The identification and classification of male infertility patients with Oligo-Astheno-Teratozoospermia into distinct TCM syndrome subtypes using the Latent Tree Model (LTM) and the Extension-Adjustment-Simplify-Transfer (EAST) algorithm. The analysis uses clinical symptoms and signs as features to cluster patients into groups. |
At the time of enrollment in the study
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Prevalence of Traditional Medicine Syndrome Subtypes
Lasso di tempo: At the time of enrollment
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The percentage distribution of each identified subtype within the study population. |
At the time of enrollment
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Statistical Characteristics of Clinical Symptoms per Syndrome
Lasso di tempo: At the time of enrollment
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The occurrence probabilities of clinical indicators within each identified cluster. This provides quantitative evidence for the symptom profiles that define each syndrome. |
At the time of enrollment
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Collaboratori e investigatori
Investigatori
- Cattedra di studio: Thi-Bay Nguyen, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
- Direttore dello studio: Minh-Man Pham Bui, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
- Direttore dello studio: Tien-Dung Ba Mai, PhD, Binh Dan Hospital
- Direttore dello studio: Kim-Oanh Thi Ngo, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigatore principale: Dai-Nhan Tran, Medical Doctor, University of Medicine and Pharmacy at Ho Chi Minh City
Pubblicazioni e link utili
Pubblicazioni generali
- Zhang NL, Yuan S, Chen T, Wang Y. Latent tree models and diagnosis in traditional Chinese medicine. Artif Intell Med. 2008 Mar;42(3):229-45. doi: 10.1016/j.artmed.2007.10.004. Epub 2007 Dec 21.
- Lu JC, Huang YF, Lu NQ. [WHO Laboratory Manual for the Examination and Processing of Human Semen: its applicability to andrology laboratories in China]. Zhonghua Nan Ke Xue. 2010 Oct;16(10):867-71. Chinese.
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 146/DHYD-HDDD
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Individual participant data that underlie the results reported in this study, after de-identification (including semen analysis parameters and Traditional Medicine clinical symptoms), will be shared with researchers who provide a methodologically sound proposal. The data will be available for the purpose of conducting meta-analysis or validating the Latent Tree Model (LTM) findings. Proposals should be directed to the Principal Investigator at nhantd97@gmail.com . To gain access, data requestors will need to sign a data access agreement and obtain approval from the study's scientific committee.
Periodo di condivisione IPD
Beginning 6 months after publication and ending 3 years after publication.
Criteri di accesso alla condivisione IPD
Requests should be directed to nhantd97@gmail.com . To gain access, data requestors will need to sign a data access agreement.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .