Efficacy Comparison of Tamoxifen and Tamoxifen With Antioxidants on Semen Quality of Male With Idiopathic Infertility
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
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.