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乏精子症・精子無力症・奇形精子症を伴う男性不妊における伝統医学的症候の評価

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

潜在木モデルによる乏精子症・精子無力症・奇形精子症を伴う男性不妊における伝統医学症候の特徴付け

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.

調査の概要

状態

完了

詳細な説明

  • 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.

研究の種類

観察的

入学 (実際)

316

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ho Chi Minh City
      • Ho Chi Minh City、Ho Chi Minh City、ベトナム
        • Binh Dan Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

男

サンプリング方法

非確率サンプル

調査対象母集団

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 .

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:CASE_ONLY
  • 時間の展望:CROSS_SECTIONAL

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Classification of Traditional Medicine Syndromes
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Prevalence of Traditional Medicine Syndrome Subtypes
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディチェア:Thi-Bay Nguyen, PhD、University of Medicine and Pharmacy at Ho Chi Minh City
  • スタディディレクター:Minh-Man Pham Bui, PhD、University of Medicine and Pharmacy at Ho Chi Minh City
  • スタディディレクター:Tien-Dung Ba Mai, PhD、Binh Dan Hospital
  • スタディディレクター:Kim-Oanh Thi Ngo、University of Medicine and Pharmacy at Ho Chi Minh City
  • 主任研究者:Dai-Nhan Tran, Medical Doctor、University of Medicine and Pharmacy at Ho Chi Minh City

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年3月1日

一次修了 (実際)

2026年7月23日

研究の完了 (実際)

2026年7月23日

試験登録日

最初に提出

2026年3月28日

QC基準を満たした最初の提出物

2026年4月9日

最初の投稿 (実際)

2026年4月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月23日

QC基準を満たした最後の更新が送信されました

2026年9月18日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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