Clinical Research Directory

Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial

This prospective randomized controlled trial will compare three treatment approaches for men with idiopathic oligoasthenoteratozoospermia (OAT), a condition characterized by abnormalities in sperm count, movement, and shape without an identified cause. Participants will be randomly assigned in a 1:1:1 ratio to receive antioxidant therapy alone, antioxidant therapy plus clomiphene citrate, or antioxidant therapy plus follicle-stimulating hormone (FSH) for 6 months. The study will evaluate whether adding clomiphene citrate or FSH to antioxidant therapy improves semen parameters compared with antioxidant therapy alone. The main outcomes will include changes in sperm concentration, motility, and morphology. The study will also assess sperm function, hormonal changes, treatment adherence, and adverse events.

Probiotics on Sperm Quality in Male Infertility Patients

This randomized, placebo-controlled pilot study aims to evaluate the effects of probiotic supplementation on sperm quality in male patients diagnosed with infertility. Male infertility accounts for approximately 40% of all infertility cases and is closely related to abnormalities in sperm count, motility, and morphology. Factors such as oxidative stress, inflammation, and DNA fragmentation are known to impact sperm function and subsequent fertilization potential negatively. Probiotics are microorganisms that confer health benefits by improving the intestinal microenvironment and regulating immunity. Emerging research suggests that probiotics may reduce oxidative stress and DNA fragmentation in men with asthenozoospermia; however, clinical data on human sperm remains limited. This study seeks to determine whether specific probiotic strains can improve sperm parameters and function in patients with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia. The study will enroll 60 male participants aged 20 to 45 who meet specific inclusion criteria, including a sperm concentration of less than 50 million/mL, motility less than 40%, and normal morphology (Kruger) less than 4%. Participants will be randomly assigned to either an experimental group receiving probiotics or a control group receiving a placebo for approximately 100 days. Semen samples will be collected and analyzed at three time points: before the intervention (Day 0), during the intervention (Day 60), and at the end of the study (Day 100). The primary objective is to assess changes in sperm concentration, motility, and morphology using the Computer-Aided Sperm Analysis (CASA) system. Secondary objectives include evaluating sperm DNA integrity using the Sperm Chromatin Structure Assay (SCSA) by flow cytometry and assessing sperm function via the acrosome reaction assay. The results of this pilot study will help determine the potential therapeutic role of probiotics in the management of male infertility.