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

Summary

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.

Timeline

Start

2026-10-15

Primary completion

2027-10-15

Completion

2028-10-15

Drugs

Indications