An observational study in Male Infertility With OAT, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 1 site in Vietnam. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Observational
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:
The research will be conducted in two phases:
Phase 2 (Clinical Survey): Researchers will recruit 300 male participants with OAT syndrome.
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.
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.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
This study's enrollment of 316 is close to the median of 300 across 17 observational studies indexed under Oligospermia.
Browse Oligospermia studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
Compared within Oligospermia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infertility, Male. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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 .
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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.
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.
Time frame: At the time of enrollment in the study
Prevalence of Traditional Medicine Syndrome Subtypes
The percentage distribution of each identified subtype within the study population.
Time frame: At the time of enrollment
Statistical Characteristics of Clinical Symptoms per Syndrome
The occurrence probabilities of clinical indicators within each identified cluster. This provides quantitative evidence for the symptom profiles that define each syndrome.
Time frame: At the time of enrollment
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Medicine and Pharmacy at Ho Chi Minh City →