Efficacy Comparison of Tamoxifen and Tamoxifen With Antioxidants on Semen Quality of Male With Idiopathic Infertility

Summary

Objective of the study is to compare the efficacy of tamoxifen alone \& tamoxifen with antioxidant on semen quality of infertile male with abnormal parameters (sperm count, motility, vitality, morphology) .Infertility is defines as inability to conceive after one year of unprotected and regular intercourse. Infertility is the most important issue in the married couples and is one of the major clinical problem affecting people medically and psychologically .It affects about 5.8 to 44.2 % couples in the developing countries. Male infertility contributes to about 50% of the overall infertility. Antiestrogens are considered as one of the old and most commonly prescribed treatment of idiopathic infertility.Many studies has shown that it improves idiopathic oligozoospermia, count, motility and vitality. Spermatozoa are also prone to oxidative damage. Men who have high reactive oxygen species(ROS) may have lower fertility potential as compared to men with low ROS. High levels of ROS in semen have been correlated with reduced sperm motility and damage to sperm nuclear DNA. High levels of cytokines in the semen is correlated with sperm injury like cell membrane lipid peroxidation in the presence of raised IL-6 .Antioxidents are the most important form of protection for spermatozoa against ROS. So oral antioxidents are commonly prescribed to males with idiopathic abnormal semen parameters and infertility to reduce the oxidative stress and improves infertility. It is a single blinded randomized control trial to be conducted in Sharif Medical and Dental college, Lahore with sampling technique of probability randomized consecutive sampling technique. 110 male patients with idiopathic male infertility and abnormal semen parameters will be recruited . Pre treatment semen analysis and LH, FSH and serum testosterone will be done. 55 patients will be given tamoxifen alone ad 55 patients will be given tamoxifen with antioxidant. Then at the interval of 3 and 6 months after treatment , semen analysis and hormonal profile will be repeated. Pre-treatment and post treatment semen parameters will be compared using paired sample t-test. P-value \< 0.05 will be taken as significant.

Timeline

Start

2021-10-15

Primary completion

2022-10

Completion

2022-10

Publications

• Results Meng Q, Ren A, Zhang L, Liu J, Li Z, Yang Y, Li R, Ma L. Incidence of infertility and risk factors of impaired fecundity among newly married couples in a Chinese population. Reprod Biomed Online. 2015 Jan;30(1):92-100. doi: 10.1016/j.rbmo.2014.10.002. Epub 2014 Oct 13.
• Results Butt F, Akram N. Semen analysis parameters: experiences and insight into male infertility at a tertiary care hospital in Punjab. J Pak Med Assoc. 2013 May;63(5):558-62.
• Results Safarinejad MR. The effect of coenzyme Q(1)(0) supplementation on partner pregnancy rate in infertile men with idiopathic oligoasthenoteratozoospermia: an open-label prospective study. Int Urol Nephrol. 2012 Jun;44(3):689-700. doi: 10.1007/s11255-011-0081-0. Epub 2011 Nov 13.
• Results Siddiq FM, Sigman M. A new look at the medical management of infertility. Urol Clin North Am. 2002 Nov;29(4):949-63. doi: 10.1016/s0094-0143(02)00085-x.
• Results 5. Iacono F, Prezioso D, Ruffo A et al. Treating idiopathic male infertility with a combination of tamoxifen citrate and a natural compost of antioxidant and androgen mimetic action. J Steroid Hormone Sci. 2013;S5: 1-6.
• Results Kadioglu TC. Oral tamoxifen citrate treatment is more effective in normogonadotropic patients who have follicle-stimulating hormone levels within the lower half of normal. Int Urol Nephrol. 2009 Dec;41(4):773-6. doi: 10.1007/s11255-009-9568-3. Epub 2009 Apr 21.
• Results Adamopoulos DA. Medical treatment of idiopathic oligozoospermia and male factor subfertility. Asian J Androl. 2000 Mar;2(1):25-32.
• Results Nada EA, El Taieb MA, Ibrahim HM, Al Saied AE. Efficacy of tamoxifen and l-carnitine on sperm ultrastructure and seminal oxidative stress in patients with idiopathic oligoasthenoteratozoospermia. Andrologia. 2015 Sep;47(7):801-10. doi: 10.1111/and.12333. Epub 2014 Oct 2.
• Results Sharma RK, Agarwal A. Role of reactive oxygen species in male infertility. Urology. 1996 Dec;48(6):835-50. doi: 10.1016/s0090-4295(96)00313-5.

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