Evaluating Traditional Medicine Syndromes in Male Infertility With Oligoasthenoteratozoospermia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-60
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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 .

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Male Infertility Patients with OAT Syndrome

Trial outcomes

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.

Time frame
At the time of enrollment in the study

Secondary outcomes

1

Prevalence of Traditional Medicine Syndrome Subtypes

The percentage distribution of each identified subtype within the study population.

Time frame
At the time of enrollment
2

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

Other outcomes

Sponsors and contacts

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