A Randomized Double arm Open labelled Comparative Study to Evaluate the Effectiveness of Homoeopathic Medicines in the Treatment of Oligospermia Patients

India is seeing a lowering sperm count trend that has been observed across the globe. This low sperm counts or Oligospermia can be caused by medical conditions or by sedentary life style that is wide spread (Agarwal et al., 2021). Oligospermia can cause difficulty in Infertility as well as difficulty in Conceiving , as well causing Psychological Distress also affecting the Quality of Life(Li et al., 2019).  Smoking, Alcohol consumption, drugs, improper diet, lack of exercise causing Obesity and ad Stress are some Life style Factors associated with a low Sperm count. Stress, a major Health concern in recent times can lead to life style and routine changes(McGrady, 1984). It could cause sudden weight changes and disrupt sleep and fertility cycles as well. Several medical conditions, sexually transmitted diseases and hormonal imbalances can also affect the sperm count. Varicocele retrograde ejaculation could lower the sperm count(Zeinali et al., 2017).  In certain cases lifestyle changes like limiting alcohol, smoking, drugs, make a shift to healthy diet and do routine exercise and reduce stress and improve sperm count.

It is estimated that infertility affects 8–12% of couples globally, with a male factor being a primary or contributing cause in approximately 50% of couples. (Agarwal et al., 2021). TheASMFR based estimate of expected level of infertility for the State of Kerala was 61 per 1000 for every married woman in the reproductive ages. Kerala a southern state in India had achieved replacement level fertility in the late 1980s, and then its Total Fertility Rate (TFR) has shown a steady decline. Currently the state is experiencing a below replacement level fertility with TFR of 1.8in 2019-21 (Thomas & Ramanathan, 2022). There is growing evidence that lifestyle choices account for the overall quality of health and life (QoL) reflecting many potential lifestyle risks widely associated with alterations of the reproductive function up to the infertility. (Ilacqua et al., 2018).

Homoeopathy is one of the safest forms of treatment for male infertility. The success rate of this treatment for male infertility is promising. Additionally, homoeopathic drugs increase sperm count and sperm abnormalities. Homoeopathic medicines which are found to be effective in male infertility or sperm count abnormalities are, Caladium, Conium Maculatum, X-ray, Agnus Castus, Selenium, Cobaltum, Titanium and so on.(Js, n.d.).

 REVIEW OF LITERATURE: -

Male factor infertility is described as presence of one or more abnormalities in the sperm analysis as well as poor sexual or ejaculatory function.  Male aging results in the loss of antioxidant activity and elevated levels of ROS. This imbalance between ROS and antioxidants causes oxidative stress and is well documented in the male reproductive tract and in the spermatozoa of aging rodents (Mueller et al., 1998) If not maintained within normal physiological levels, ROS can damage cellular macromolecules, inducing stress signalling and, at high levels, cell death.

In humans, although spermatozoa are continuously produced with advanced paternal age, there is a growing body of evidence indicating that advanced paternal age is associated with negative impact on the quality of male germ cells (Lawson & Fletcher, 2014) the number of Sertoli cells  and the number of Leydig cells (NEAVES et al., 1984). In a study it was found that compared to the age group 18–40 years, men aged > 75 years had 31% smaller mean testicular volume. (Johnson et al., 1988) In addition, some authors reported the thickening of basal membrane of seminiferous tubules with age  as well as disturbances in blood supply in senile testes have been associated with negative changes in spermiogenesis and thickness of basement membrane. Male aging is characterized by different changes in the endocrine function. Hormonal changes are characterized mainly by a reduction of the biosynthesis of testicular inhibin B by Sertoli cells with increased secretion of follicle stimulating hormone (FSH). Leydig cells are responsible for testosterone production. The number of Leydig cells tends to reduce with increasing paternal age . The average total number of Leydig cell nuclei decreases by half in age group of 50–76 years compared to age group of 20–48 years. Wu et al. reported that age-affected testicular atrophy is a result of Hypothalamic-Pituitary-Testicular Axis alterations that disturb the function. (NEAVES et al., 1984).

Tribulus terrestris L. is an herbal plant that has long been used as sex stimulant and to treat male infertility. This systematic review collected the clinical trials and/or quasi-experimental studies on the effect of T. terrestris on sperm parameters in idiopathic male infertility. To search the related articles, Cochrane Library, EMBASE, ProQuest, Clinicaltrial.gov, WHO, Google Scholar, MEDLINE via Pubmed, Web of Science, SID, Magiran, Irandoc, and Iranmedex databases were used without any time limitation. Words used to search were T. terrestris L., Tribestan, male infertility and sperm parameters based on the MeSH glossary. To assess the eligibility of the articles, the views of the two authors and in cases where there was no agreement, the third person was used. Through searching of the databases, 5775 articles were identified, of which 3509 were entered after removing the duplicates. Afterward, 102 articles were screened for inclusion. Finally, 7 articles were included in this systematic review. Only one quasi-experimental without control arm article reported that the use of T. terrestris L. in the treatment of idiopathic male infertility was not effective, In the others, T. terrestris L. was reported to be effective in improving some or all parameters of the sperm, namely number, motility and morphology.The results of the present systematic review showed that the consumption of T terrestris L., in general, resulted in the improvement of sperm parameters. This result was obtained from 6 out of the 7 articles.(Sanagoo et al., 2019). Scientific evidence supports the use of mucuna and ashwagandha as phytotherapics for improving serum T concentrations and semen parameters. Despite inconclusive evidence for use of tribulus as a T booster, it may provide advantageous effects on sperm parameters in men with idiopathic infertility.(Santos et al., 2019).