Fixed Dose Combination Therapy of Antioxidants in Treatment of Idiopathic Oligoasthenozoospermia: Results of a Randomized, Double-blind, Placebo-controlled Clinical Trial

JOURNAL TITLE: International Journal of Infertility & Fetal Medicine

Author
1. Ajit Saxena
2. Sonia Malik
3. Sanjay Kalra
4. Bharti Kalra
5. Kapil Kochhar
6. Hemant Zaveri
ISSN
2229-3817
DOI
10.5005/jp-journals-10016-1053
Volume
4
Issue
1
Publishing Year
2013
Pages
8
Author Affiliations
    1. CGHS, Chandigarh, India
    2. Holy Angels Hospital, New Delhi, India
    3. Southend Fertility and IVF Centre, Holy Angels Hospital, Delhi
    4. Southend Rotunda Center for Human Reproduction, Holy Angels Hospital, Vasant Lok, Vasant Vihar, New Delhi, India
    5. Southend Rotunda, Center for Human Reproduction, Holy Angels Hospital, Vasant Vihar, New Delhi
    6. National Institute of Communicable diseases, New Delhi, India
    7. Southend-Rotunda Center for Human Reproduction, Holy Angels Hospital, New Delhi, India
    8. Southend Fertility and IVF Centre, Holy Angels Hospital, Vasant Lok, Vasant Vihar, New Delhi, India, E-mail: sm_doc@rediffmail.com; sm_doc@hotmail.com
    9. Southend Rotunda (Centre for Human Reproduction), Holy Angels Hospital, Vasant Vihar New Delhi
    10. Southend Fertility and IVF Center, Holy Angels Hospital, Vasant Vihar, New Delhi, India
    11. Southend Fertility and IVF Center, Holy Angels Hospital, New Delhi, India
    12. Southend Fertility and IVF Center, New Delhi, India
    13. Southend Fertility and IVF Centre, New Delhi, India
    14. Southend Fertility and IVF Centers, Delhi NCR, India
    15. Southend Fertility & IVF Centres, New Delhi, India
    16. Southend Infertility and IVF Centres, New Delhi
    17. Southend Fertility and IVF, New Delhi, India
    18. Southend Fertility and IVF Center, Mumbai, Maharashtra, India
    19. Southend Fertility and IVF, New Delhi, India; Southend Fertility and IVF, New Delhi, India; Indian Fertility Society; FOGSI Infertility Committee
    20. IVF, New Delhi, India
    21. Southend Fertility and IVF, Delhi NCR, India
    22. Southend Fertility & IVF, New Delhi, India
    1. Bharti Hospital, Karnal, Haryana, India
    2. Bharti Hospital and B.R.I.D.E., Karnal 132 001, Haryana, India
    3. Bharti Hospital and BRIDE Karnal; Indian J Endocrinology Metabolism, Bharti Hospital, Karnal, Haryana, India
    4. Bharti Hospital, Karnal-132001, Haryana, India
    5. Indian J Endocrinology and Metabolism; J of Social Health in Diabetes (JoSH Diabetes), Bharti Hospital and BRIDE, Karnal, Haryana, India
    6. Bharti Hospital and BRIDE, Karnal, Haryana, India
    1. Indraprastha Apollo Hospitals, New Delhi.
    2. Indraprastha Apollo Hospitals, New Delhi, India
    1. Bharti Hospital & BRIDE, Karnal-132001, Haryana, India
    2. Bharti Hospital and BRIDE, Karnal, Haryana, India
    3. Bharti Hospital, Karnal, Haryana, India
    1. Department of Andrology, Men's Health Clinic Indore, Madhya Pradesh, India
  • Article keywords

    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.

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