Traditional medicine patterns in men with oligoasthenoteratozoospermia

Characterization of Traditional Medicine Syndromes in Male Infertility With Oligoasthenoteratozoospermia Via Latent Tree Models

This project will see if the Traditional Medicine syndromes described in the literature match the symptoms reported by men aged 18–60 with OAT by reviewing texts and surveying about 300 patients at Binh Dan Hospital.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Male
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City (other)
• Locations: 1 site (Ho Chi Minh City, Ho Chi Minh City)
• Trial ID: NCT07529288 on ClinicalTrials.gov

What this trial studies

The project uses a two-phase approach: first compiling and standardizing Traditional Medicine symptoms and syndromes from classical and modern TM literature using WHO terminologies, then applying a clinical questionnaire to roughly 300 men with OAT at Binh Dan Hospital. Symptoms appearing in the literature at greater than 30% frequency will form the survey items. Clinical responses will be analyzed with Latent Tree Models to identify objective groupings of TM syndromes and their symptom distributions. The goal is to produce a standardized, data-driven map of TM syndrome patterns in men with OAT.

Who should consider this trial

Good fit: Men aged 18–60 who have been diagnosed with male infertility and meet WHO criteria for oligoasthenoteratozoospermia, can give informed consent, and do not meet any exclusion criteria.

Not a fit: Patients with azoospermia, genetic or chromosomal causes of infertility, structural reproductive abnormalities, recent use of medications known to affect spermatogenesis, or those unable to understand the procedures are excluded and unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the work could standardize TM syndrome definitions for men with OAT and help clinicians link symptom patterns to targeted TM-informed care or further research.

How similar studies have performed: Prior clinical reports suggest some Traditional Medicine approaches can improve semen parameters, but objective classification of TM syndromes using Latent Tree Models is a novel, not yet widely validated approach.

Eligibility criteria

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.

Where this trial is running

Ho Chi Minh City, Ho Chi Minh City

• Binh Dan Hospital — Ho Chi Minh City, Ho Chi Minh City, Vietnam (RECRUITING)

Study contacts

• Principal investigator: Dai-Nhan Tran, Medical Doctor — University of Medicine and Pharmacy at Ho Chi Minh City
• Study coordinator: Minh-Man Pham Bui, PhD

Conditions: Male Infertility With OAT, Traditional Medicine Pattern, OAT, Male Infertility, Oligoasthenoteratozoospermia