ABSTRACT
Introduction
To assess the effectiveness and safety of fixed dose combination (FDC) of antioxidants in treatment of idiopathic oligoasthenozoospermia.
Materials and methods
Placebo-controlled, Double-blind, randomized, Parallel three arm, Multicentric trial.
Setting
Fertility clinics of five centers across India.
Patients
One hundred and thirty-eight male subjects, aged between 21 and 50 years and subfertile for 1 year or more with the following baseline sperm selection criteria: Concentration <15 million/ml and total sperm motility <40%.
Intervention(s)
Eligible subjects were randomized to either of the three arms in a double-blind manner, i.e. arm 1 was given 2 tablets twice daily of FDC of antioxidants (coenzyme-Q10: 50 mg, L-carnitine: 500 mg, lycopene: 2.5 mg and zinc: 12.5 mg); arm 2 was given 1 tablet of FDC of antioxidants and one tablet of placebo twice daily and arm 3 was two tablets twice daily of matching placebo all for 180 days.
Main outcome measure(s)
The primary outcome measures were improvement in sperm count and sperm motility, whereas pregnancy rate was the secondary efficacy outcome.
Results
Compared to placebo, a statistically significant improvement was seen in sperm count (14.8-26.35 in arm 1 and 14.37-24.8 million/ml in arm 2, p < 0.0001), and sperm total motility (39.2-51.6% in arm 1 and 38.4-50.1% in arm 2, p < 0.0001), at 90 days, and treatment further improved these parameters at day 180. No intergroup difference was seen between arm 1 and arm 2. Mild adverse event of upper gastrointestinal discomfort by 8 subjects (three in arm 1; one in arm 2 and four subjects in arm 3) were reported. No serious adverse event was seen in the study.
Conclusion
Exogenous administration of fixed dose combination of antioxidants is a safe and effective therapy in improving the male subfertility.
How to cite this article
Gopinath PM, Kalra B, Saxena A, Malik S, Kochhar K, Kalra S, Zaveri H. Fixed Dose Combination Therapy of Antioxidants in Treatment of Idiopathic Oligoasthenozoospermia: Results of a Randomized, Doubleblind, Placebo-controlled Clinical Trial. Int J Infertility Fetal Med 2013;4(1):6-13.
A pilot double-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy (‘polypill’) on cardiovascular risk factors
