Characterization of Traditional Medicine Syndromes in Male Infertility With Oligoasthenoteratozoospermia Via Latent Tree Models
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Classification of Traditional Medicine Syndromes
研究概览
简要总结
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.
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Participants will answer a survey questionnaire about their Traditional Medicine symptoms.
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Researchers will apply Latent Tree Models (a mathematical approach) to the collected data to objectively classify the TM syndromes.
详细描述
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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.
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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.
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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.
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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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Male Infertility Patients with OAT Syndrome
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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:
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Oligozoospermia: Sperm concentration < 15 million/mL or total sperm count < 39 million.
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Asthenozoospermia: Progressive motility < 32%.
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Teratozoospermia: Normal morphology < 4%.
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Participants are recruited from the Department of Andrology at Binh Dan Hospital, Ho Chi Minh City. The study excludes individuals with:
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Genetic or chromosomal abnormalities (e.g., Klinefelter syndrome, XYY syndrome).
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Structural abnormalities of the reproductive organs.
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Azoospermia (no sperm in the ejaculate).
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Recent use (within the last 3 months) of medications known to affect spermatogenesis, such as anabolic steroids or certain calcium channel blockers.
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Inability to communicate or participate in the survey.
结局指标
主要结局
Classification of Traditional Medicine Syndromes
时间窗: 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.
次要结局
- Prevalence of Traditional Medicine Syndrome Subtypes(At the time of enrollment)
- Statistical Characteristics of Clinical Symptoms per Syndrome(At the time of enrollment)
研究者
Bui Pham Minh Man
Investigator
University of Medicine and Pharmacy at Ho Chi Minh City