- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07529288
과소활동성기형정자증을 동반한 남성 불임의 전통 의학 증후군 평가
잠재 트리 모델을 통한 올리고무정자증 남성 불임에서의 전통 의학 증후군 특성화
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.
연구 개요
상태
상세 설명
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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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ho Chi Minh City
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Ho Chi Minh City, Ho Chi Minh City, 베트남
- Binh Dan Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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 .
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
|---|
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Male Infertility Patients with OAT Syndrome
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Classification of Traditional Medicine Syndromes
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of Traditional Medicine Syndrome Subtypes
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: Thi-Bay Nguyen, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
- 연구 책임자: Minh-Man Pham Bui, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
- 연구 책임자: Tien-Dung Ba Mai, PhD, Binh Dan Hospital
- 연구 책임자: Kim-Oanh Thi Ngo, University of Medicine and Pharmacy at Ho Chi Minh City
- 수석 연구원: Dai-Nhan Tran, Medical Doctor, University of Medicine and Pharmacy at Ho Chi Minh City
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 146/DHYD-HDDD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
Beginning 6 months after publication and ending 3 years after publication.
IPD 공유 액세스 기준
Requests should be directed to nhantd97@gmail.com . To gain access, data requestors will need to sign a data access agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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