Male Infertility With OATNCT07529288
Evaluating Traditional Medicine Syndromes in Male Infertility With Oligoasthenoteratozoospermia
An observational study of Male Infertility With OAT, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Male Infertility With OAT
- How many people
- 316 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2026to 23 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: 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 .
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Traditional Medicine Syndromes in Male Infertility With Oligoasthenoteratozoospermia Via Latent Tree Models
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?
Read more
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.
Read the detailed description
- 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.
- Conditions
- Male Infertility With OAT
- Keywords
- Traditional Medicine Pattern, OAT, Male Infertility, Oligoasthenoteratozoospermia
- Medical subject headings
- Infertility, Male, Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of enrollment in the study
Secondary outcomes (2)
Prevalence of Traditional Medicine Syndrome Subtypes
The percentage distribution of each identified subtype within the study population.
Measured: 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.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Mar 2026
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Male Infertility With OATStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Thi-Bay Nguyen, PhD, Study chair, University of Medicine and Pharmacy at Ho Chi Minh CityMinh-Man Pham Bui, PhD, Study director, University of Medicine and Pharmacy at Ho Chi Minh CityTien-Dung Ba Mai, PhD, Study director, Binh Dan HospitalKim-Oanh Thi Ngo, Study director, University of Medicine and Pharmacy at Ho Chi Minh CityDai-Nhan Tran, Medical Doctor, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529288
- Sponsor's protocol ID
- 146/DHYD-HDDD
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 18096374Lu 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.
PubMed 21243747
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Traditional Medicine Syndromes in Male Infertility With Oligoasthenoteratozoospermia Via Latent Tree Models
- ClinicalTrials.gov ID
- NCT07529288
- Acronym / sponsor ID
- 146/DHYD-HDDD
- Conditions
- Male Infertility With OAT
- Keywords
- Traditional Medicine Pattern, OAT, Male Infertility, Oligoasthenoteratozoospermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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 .
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Classification of Traditional Medicine Syndromes
Time frame: 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.
2 secondary outcomes
Prevalence of Traditional Medicine Syndrome Subtypes
Time frame: At the time of enrollment
Statistical Characteristics of Clinical Symptoms per Syndrome
Time frame: At the time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 18096374Zhang 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.
- Background: PubMed 21243747Lu 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.
- Individual participant dataSharing planned: 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.
Related trials for Male Infertility With OAT
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Oligoasthenoteratozoospermia, Male Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thi-Bay Nguyen, PhD study chair
University of Medicine and Pharmacy at Ho Chi Minh City
Minh-Man Pham Bui, PhD study director
University of Medicine and Pharmacy at Ho Chi Minh City
Tien-Dung Ba Mai, PhD study director
Binh Dan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility With OAT, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of Traditional Medicine Syndromes (time frame: At the time of enrollment in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07529288, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.