Evaluating Traditional Medicine Syndromes in Male Infertility With Oligoasthenoteratozoospermia
Characterization of Traditional Medicine Syndromes in Male Infertility With Oligoasthenoteratozoospermia Via Latent Tree Models
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2026
CompletedFirst Submitted
Initial submission to the registry
March 28, 2026
CompletedFirst Posted
Study publicly available on registry
April 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
April 14, 2026
April 1, 2026
8 months
March 28, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Classification of Traditional Medicine Syndromes
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
Secondary Outcomes (2)
Prevalence of Traditional Medicine Syndrome Subtypes
At the time of enrollment
Statistical Characteristics of Clinical Symptoms per Syndrome
At the time of enrollment
Study Arms (1)
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.
Eligibility Criteria
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 .
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Binh Dan Hospital
Ho Chi Minh City, Ho Chi Minh City, Vietnam
Related Publications (2)
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.
PMID: 18096374BACKGROUNDWHO laboratory manual for the examination and processing of human semen, 6th ed
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thi-Bay Nguyen, PhD
University of Medicine and Pharmacy at Ho Chi Minh City
- STUDY DIRECTOR
Minh-Man Pham Bui, PhD
University of Medicine and Pharmacy at Ho Chi Minh City
- STUDY DIRECTOR
Tien-Dung Ba Mai, PhD
Binh Dan Hospital
- STUDY DIRECTOR
Kim-Oanh Thi Ngo
University of Medicine and Pharmacy at Ho Chi Minh City
- PRINCIPAL INVESTIGATOR
Dai-Nhan Tran, Medical Doctor
University of Medicine and Pharmacy at Ho Chi Minh City
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
March 28, 2026
First Posted
April 14, 2026
Study Start
January 14, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 6 months after publication and ending 3 years after publication.
- Access Criteria
- Requests should be directed to nhantd97@gmail.com . To gain access, data requestors will need to sign a data access agreement.
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.