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Évaluation des syndromes de médecine traditionnelle dans l'infertilité masculine avec oligoasthénotératozoospermie

18 septembre 2026 mis à jour par: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

Caractérisation des syndromes de médecine traditionnelle dans l'infertilité masculine avec oligoasthénotératozoospermie via des modèles d'arbres latents

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:

  • 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.

  • 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.

Aperçu de l'étude

Statut

Complété

Description détaillée

  • 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.

  • 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.
  • 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.

Type d'étude

Observationnel

Inscription (Réel)

316

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Ho Chi Minh City
      • Ho Chi Minh City, Ho Chi Minh City, Viêt Nam
        • Binh Dan Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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 .

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: CASE_ONLY
  • Perspectives temporelles: CROSS_SECTIONAL

Cohortes et interventions

Groupe / Cohorte
Male Infertility Patients with OAT Syndrome
  • Men aged 18 to 60 years who are diagnosed with male infertility and present with Oligoasthenoteratozoospermia (OAT) syndrome. According to the World Health Organization (WHO) standards, OAT is defined by the following concurrent semen parameters:

    • Oligozoospermia: Sperm concentration < 15 million/mL or total sperm count < 39 million.
    • Asthenozoospermia: Progressive motility < 32%.
    • Teratozoospermia: Normal morphology < 4%.
  • Participants are recruited from the Department of Andrology at Binh Dan Hospital, Ho Chi Minh City. The study excludes individuals with:

    • Genetic or chromosomal abnormalities (e.g., Klinefelter syndrome, XYY syndrome).
    • Structural abnormalities of the reproductive organs.
    • Azoospermia (no sperm in the ejaculate).
    • Recent use (within the last 3 months) of medications known to affect spermatogenesis, such as anabolic steroids or certain calcium channel blockers.
    • Inability to communicate or participate in the survey.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Classification of Traditional Medicine Syndromes
Délai: At the time of enrollment in the study

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Prevalence of Traditional Medicine Syndrome Subtypes
Délai: At the time of enrollment

The percentage distribution of each identified subtype within the study population.

At the time of enrollment
Statistical Characteristics of Clinical Symptoms per Syndrome
Délai: At the time of enrollment

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Thi-Bay Nguyen, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
  • Directeur d'études: Minh-Man Pham Bui, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
  • Directeur d'études: Tien-Dung Ba Mai, PhD, Binh Dan Hospital
  • Directeur d'études: Kim-Oanh Thi Ngo, University of Medicine and Pharmacy at Ho Chi Minh City
  • Chercheur principal: Dai-Nhan Tran, Medical Doctor, University of Medicine and Pharmacy at Ho Chi Minh City

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2026

Achèvement primaire (Réel)

23 juillet 2026

Achèvement de l'étude (Réel)

23 juillet 2026

Dates d'inscription aux études

Première soumission

28 mars 2026

Première soumission répondant aux critères de contrôle qualité

9 avril 2026

Première publication (Réel)

14 avril 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

Beginning 6 months after publication and ending 3 years after publication.

Critères d'accès au partage IPD

Requests should be directed to nhantd97@gmail.com . To gain access, data requestors will need to sign a data access agreement.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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