Clinical Research Directory

AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism

AIM-TEST is a randomized, double-blind, placebo-controlled clinical trial evaluating whether an AI-guided, microbiome-targeted nutritional intervention can increase the body's own testosterone production in men aged 30-65 years with symptomatic, biochemically confirmed functional secondary hypogonadism. Functional secondary hypogonadism is characterized by symptoms of testosterone deficiency together with repeatedly low morning testosterone levels and low or inappropriately normal gonadotropin levels, without evidence of primary testicular failure or an organic hypothalamic or pituitary disorder. Men may be included regardless of their body weight or obesity status, provided that their low testosterone has been appropriately confirmed and does not require urgent disease-specific or hormonal treatment. Participants will be randomly assigned to receive either the active nutritional supplement or a matched placebo once daily for 12 weeks. The main question is whether the active intervention produces a greater increase in morning total testosterone than placebo. The study will also assess calculated free testosterone, symptoms of androgen deficiency, sexual function, metabolic and inflammatory markers, gut microbiome changes, treatment tolerability, and safety. Participants will be followed for an additional 12 weeks after stopping the study product to explore whether any observed effects are maintained. The study hypothesis is that the microbiome-targeted intervention will result in a greater improvement in endogenous testosterone levels than placebo. This is a proof-of-concept study and is not intended to replace standard diagnostic evaluation or established treatment when these are clinically required.

Intratesticular Artery Resistive Index Changes After Varicocelectomy

This study aims to evaluate how blood flow inside the testicles changes after surgery to correct a varicocele, and whether these changes correlate with improvements in semen quality and testosterone levels. Varicocele is a common, treatable cause of male infertility that can negatively affect testicular function by altering blood flow and temperature. While surgery (varicocelectomy) often improves fertility, doctors are continually looking for ways to predict which patients will benefit the most from the procedure. This study uses scrotal color Doppler ultrasound to measure the Intratesticular Artery Resistive Index (RI), which is an indicator of blood flow resistance and microvascular health, before and after surgery. Researchers will recruit 40 infertile men with clinically palpable varicoceles. Participants will undergo a baseline evaluation that includes a physical exam, semen analysis, a blood test for total testosterone, and a specialized ultrasound to measure the RI under different physical conditions (lying down, standing, and during a Valsalva maneuver/bearing down). All participants will then undergo a microscopic sub-inguinal varicocelectomy, which is the standard microsurgical treatment. Three months after the surgery, participants will return for follow-up testing to repeat the semen analysis, testosterone blood test, and ultrasound. The main goal of the study is to determine if pre-operative RI measurements can serve as an early, reliable predictor of surgical success, specifically looking at the recovery of testicular function, sperm parameters, and hormonal levels.