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评估少弱畸精子症男性不育症中的传统医学证候

2026年9月18日 更新者:Bui Pham Minh Man、University of Medicine and Pharmacy at Ho Chi Minh City

基于潜在树模型对少弱畸形精子症男性不育传统医学证型的特征分析

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.

研究概览

地位

完全的

详细说明

  • 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.

研究类型

观察性的

注册 (实际的)

316

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ho Chi Minh City
      • Ho Chi Minh City、Ho Chi Minh City、越南
        • Binh Dan Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

男性

取样方法

非概率样本

研究人群

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 .

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_ONLY
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Classification of Traditional Medicine Syndromes
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Prevalence of Traditional Medicine Syndrome Subtypes
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Thi-Bay Nguyen, PhD、University of Medicine and Pharmacy at Ho Chi Minh City
  • 研究主任:Minh-Man Pham Bui, PhD、University of Medicine and Pharmacy at Ho Chi Minh City
  • 研究主任:Tien-Dung Ba Mai, PhD、Binh Dan Hospital
  • 研究主任:Kim-Oanh Thi Ngo、University of Medicine and Pharmacy at Ho Chi Minh City
  • 首席研究员:Dai-Nhan Tran, Medical Doctor、University of Medicine and Pharmacy at Ho Chi Minh City

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月1日

初级完成 (实际的)

2026年7月23日

研究完成 (实际的)

2026年7月23日

研究注册日期

首次提交

2026年3月28日

首先提交符合 QC 标准的

2026年4月9日

首次发布 (实际的)

2026年4月14日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

IPD 共享时间框架

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

IPD 共享访问标准

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

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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