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Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
Sponsor: Hamad Medical Corporation
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.
Key Details
Gender
MALE
Age Range
21 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-10-15
Completion Date
2028-10-15
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Antioxidants + Clomiphene Citrate
Participants will receive the same antioxidant regimen as the active comparator arm plus clomiphene citrate 50 mg orally every other day for 6 months.
Antioxidants + FSH
Participants will receive the same antioxidant regimen plus FSH 150 IU administered subcutaneously three times weekly for 6 months.
Antioxidants Alone
Participants will receive antioxidant therapy consisting of vitamin C 1000 mg/day, vitamin E 400 IU/day, L-carnitine, and zinc 25 mg/day for 6 months
Locations (1)
Ambulatory Care Center (ACC), Hamad Medical Corporation
Doha, Baladiyat ad Dawhah, Qatar