RecruitingNot Applicable

Evaluating Traditional Medicine Syndromes in Male Infertility With Oligoasthenoteratozoospermia

Vietnam300 participantsStarted 2026-01-14

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Classification of Traditional Medicine Syndromes

Timeframe: At the time of enrollment in the study

Trial details

NCT IDNCT07529288

SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-31

Contact for this trial

Minh-Man Pham Bui, PhD

+84916080803 bpmman@uhsvnu.edu.vn

View on ClinicalTrials.gov More Male Infertility With OAT trials