Comparison of the Efficacy of the Tamoxifen and Tamoxifen With Antioxidants on Semen Quality of Infertile Male With Abnormal Semen Parameters.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Total sperm Count
研究概览
简要总结
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.
详细描述
Infertility is considered as the most important issue among the married couples and it represents major clinical problems affecting people not just medically but also psychologically .
Infertility affects about 5-8% of couple in developed countries and 5.8 - 44.2% in developing nations. In Pakistan incidence of oligozoospermia is around 21 percent and 12.32 % of patients presents with azoospermia (2). Male infertility contributes to about 50% of the cases of infertility . Cause of male infertility with abnormal semen parameters remains unknown in about 25% of men Men with idiopathic infertility may receive number of empirical therapies by clinicians. Commonly prescribed medications include hormonal medications such as follicular stimulating hormone (FSH), androgens like testosterone and mesterolone, antiestrogens ( tamoxifine, clomiphene citrate) , antioxidents like vitamin E, glutathione and sperm vitalizer such as L-carnitine ,coQ10.
Antiestrogens are considered to be one of the oldest and most commonly prescribed treatment for the idiopathic male infertility. Antiestrogen given for 6-9 months reported to have pregnancy rate of 20-40% . According to WHO tamoxifen citerate is the first line treatment for idiopathic ologozoospermia . Previously tamoxifen citrate was given as the empirical treatment for oligozoospermia and later it was found that after the use of 3-6 months it improves sperm count, motility and viability . The exact mechanism by which tamoxifen increase sperm parameters is not known , however it is found that it has stimulatory action on gonadotrophin secretion and directly effects leydig cell function . Tamoxifen is also known for the treatment of breast cancer worldwide.
Oxidative stress has been widely studied previously as one of the cause of the male infertility. Like other aerobic cells , spermatozoa are also prone to the oxidative damage because they have large polyunsaturated fat content in their membrane. 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 . Interferone gamma and TNF alpha have shown to decrease the motility of spermatozoa. This is commonly present in genitourinary infections and inflammation in which oxidative mechanism can leads to oxidative stress . 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.
Though assisted reproductive techniques are being widely offered to infertile couples, however before referring the patients for these expensive treatment options , relatively economical and practical methods should be considered first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
It is single blinded study in which 110 patients are recruited into two groups .Randomization will be done by lottery method to divide the patients into group A & group B. 55 patients in group A will be given tamoxifen 10 mg twice a day and 55 patients in group B will be given tamoxifen 10 mg twice a day and vit E 400mg once a day. Only researcher will be knowing that which treatment will be giving to which group.
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All infertile male with idiopathic infertility and abnormal semen analysis.
排除标准
- •Leukocytospermia i.e. significant WBCs seen in the semen,
- •Severe oligospermia (sperm count <5 million per ml),
研究组 & 干预措施
"Tamoxifen"
Group A patients will receive tab tamoxifen 10 mg twice a day for total of six months.
干预措施: Tab Tamoxifen 10 mg (Drug)
"Tamoxifen and Antioxidant"
Group B patients will receive tab tamoxifen 10 mg twice a day and cap. vit E 400mg once a day for total of six months.
干预措施: Tab Tamoxifen 10mg,Cap vitamin E 400mg (Drug)
结局指标
主要结局
Total sperm Count
时间窗: 6 months posttreatment
Total Sperm No.(x106):
Sperm concentration
时间窗: 6 months posttreatment
Sperm Conc. (x106)/ ejeculate:
Follicular stimulating hormone
时间窗: 6 months posttreatment.
Follicular stimulating hormone (LH) measured in mU/ml Follicular stimulating hormone (FSH) measured in mU/ml
Serum Testosterone
时间窗: 6 months posttreatment.
Serum Testosterone measured in ng/dl
Progressive motility
时间窗: 6 months posttreatment
Progressive motility (Percentage %):
Sperm Morphology:
时间窗: 6 months posttreatment
Sperm Morphology: Percentage %
Vitality
时间窗: 6 months posttreatment
Vitality (live spermatozoa) in percentage%
Semen Volume
时间窗: at 6 months posttreatment
Semen Volume measured in ml.
Leutinizing hormone
时间窗: 6 months posttreatment
Leutinizing hormone (LH) measured in mU/ml
次要结局
未报告次要终点
