Effect of Yoga on Semen Quality, Cardiometabolic and Psycho-Neuro-Endocrine-Immune Parameters in Male Partners of Infertile Couples with Psychological Stress: A Randomized Controlled Trial

Infertility ranked as the fifth highest serious global disability WHO affects 17.5% of adults globally, or roughly 1 in 6 individuals with a lifetime prevalence estimated to 17.8% in high-income countries and 16.5% in low and middle-income countries. In India, approximately 16% of ever-married women of reproductive age are childless. Infertility can manifest as either primary or secondary infertility.  WHO has described infertility as “a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse”. Notably, a male component is implicated in about 50% of cases, either independently (20%) or in conjunction with a female factor.

Idiopathic male infertility accounts for 25% of cases. Over recent decades, a decline in semen quality has been documented globally and the prevalence of unexplained infertility with normal semen parameters is also on the rise. Alongside established risk factors such as environmental influences, endocrine disruptors, and unhealthy lifestyles. A meta-analysis reported that psychological stress in men facing infertility ranges from 14% to 23% worldwide with the incidence of emotional and mental disorders especially anxiety and depression in them reported to be 25–60%. A meta-analysis involving 57 cross-sectional studies conducted revealed that psychological stress inversely affects sperm quality. Meta-analysis by Fisher et al.  reported a marginal increase in oestradiol, decreased testosterone, increased cortisol, inconclusive results on follicle-stimulating hormone (FSH) and inconclusive or luteinizing hormone (LH) levels in patients with psychological stress compared with healthy controls. Although the primary effect of psychological stress reported is suppression of testosterone, the mechanism by which this suppression is mediated is unclear.

It has been postulated that there might be some unknown inhibitors released during chronic psychological stress that could affect testosterone levels and other neuroendocrine hormones. A systematic review by Shamoon et al. reported that chronic stress produces adaptations in the immunological system, upregulating pro-inflammatory cytokines, especially IL-6 and glucocorticoids possibly through the activation of sympathetic nervous system. From increasing clinical and experimental evidence, a paradigm is emerging that cytokines, regulated by psycho-neuroendocrine processes, especially IL-6, can impact fertility and gonadal function by altering hormone production and responsiveness within the hypothalamus-pituitary axis. Yoga is a holistic mind-body practice for stress reduction and modulation of inflammatory and neuroendocrine pathways. While there is some research on the impact of psychological stress on male reproductive health and the potential benefits of yoga, these areas remain relatively understudied. To the best of our knowledge, this is the first study to explore the potential therapeutic benefits of yoga on inflammation, hormone regulation, and semen quality in men with psychological stress and no similar studies have been reported. Investigating the effects of yoga on male partners of infertile couples with psychological stress has the potential to provide novel insights into therapeutic application of yoga for improving reproductive health outcomes. Hence in the present study the effect of yoga on semen quality, inflammatory markers, neuroendocrine hormones and psychological parameters in Male partners of Infertile couple with psychological stress compared to a control group has been proposed to be studied using Parallel group, single blinded, Randomized Controlled Trial.

Initially data collection tool will be used for screening after informed and written consent. Eligible participants who fulfil the inclusion and exclusion criteria will be screened for stress using PSS.  Subjects with PSS score ≥ 14 will be included in the study by consecutive sampling technique. Manual semen analysis will beperformed as per WHO guidelines 6th edition. Semen obtained by masturbation after 4 days of abstinence and ejaculated into a wide mouthed plastic container will be used for analysis. Sperm motility, count, morphology and vitality will be assessed after liquefaction of semen at room temperature within maximum one hour of ejaculation. Participants having azoospermia (no spermatozoa in the ejaculate), ≥1 x 106 leucocytes or agglutination in semen will be excluded from the study. Scheduling of eligible participants for randomization will be done after an abstinence period of 4 days.  On the scheduled date, Block randomization will be done, and participants will be allocated to intervention (8 weeks yoga therapy and standard care) or control group (standard care). Single blinding will be done.  Semen parameters, inflammatory markers, neuroendocrine hormone levels (total testosterone, DHEAS, FSH, LH, prolactin, oestradiol, cortisol), heart rate variability, autonomic function tests and psychological parameters will be assessed pre and post intervention in both the groups. Success rate of conception will be followed up in the participants for 6 months. The data collected will be analysed using SPSS IBM software version 29. Test of normality will be done, and normally distributed data will be presented as mean + standard deviation (SD) and variables without normal distribution will be presented as median (interquartile range). Parametric test (Independent t test) will be used to compare variables with normal distribution and non-parametric test (Mann Whitney U test) will be used to compare variables without normal distribution between the groups at the end of 8 weeks. Paired test will be used to compare the variables with normal distribution and Wilcoxon Signed Rank test will be used to compare variables without normal distribution between pre and post 8 weeks in each group respectively. Pearson’s correlation or Spearman’s rank correlation will be used for correlation. p-value< 0.05 (2-tailed) will be considered to be statistically significant. The expected benefits are improved semen quality, physical fitness and psychological wellbeing to the participation in the yoga intervention, better scientific understanding of the complex interplay between psychological stress, immune response, hormonal levels and semen quality. The study could contribute to the scientific understanding of complementary interventions for male infertility and provides valuable data for future research and clinical practice.

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