A New Immune-Biochemical Study To Identify Indicators Of The Response Of Infertile Polycystic Ovary Syndrome Patients To Metformin Treatment

Abstract

Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting women throughout their lifespan. The prevalence of PCOS varies depending on the population studied, but it is estimated to affect between 10% and 13% or ∼140 million women globally. PCOS in adults is diagnosed according to the International Evidence-based Guideline Criteria based on two of either ovulatory dysfunction, clinical or biochemical hyperandrogenism, and/or polycystic ovary morphology (PCOM) on ultrasound or elevated anti-Müllerian hormone levels. Infertility is a serious global health problem affecting an estimated 50 to 70 million couples worldwide. Infertility is a condition in which pregnancy does not occur even after regular unprotected sex for more than one yearو for women under 35 years of age, a couple's failure to conceive after 12 months of regular sexual activity without using contraception, and after 6 months for women 35 years of age or older. Infertility results in disability expressed through impaired function, social exclusion, and psychological trauma; thus, it is ranked by the World Health Organization as the fifth highest serious disability worldwide. Population of the study: This study included samples of 90 women of reproductive age (20-40 years). They were distributed into three groups. The first:  included 30 patients undergoing treatment for infertility due to PCOS, the second group included 30 patients who were diagnosed with PCOS through the simultaneous appearance of 3-4 symptoms that are essential for diagnosis. The third group (the control group) included 30 women who were completely free of symptoms of PCOS and all of whom had children without any medical intervention and did not suffer from any disease, based on clinical examinations and ultrasound examinations.

Kits and technique: Sandwich-ELISA technique was applied to determine the level of integrin, CLEC10A and interleukin-42 in the serum samples of the study individuals.

Results: Respectable statistical differences in integrin levels were observed when comparing the group of PCOS patients treated with infertility drugs (p=0.000), as well as the untreated PCOS patients (p=0.010) with the healthy control group. The results showed a significant elevation in CLEC10A levels comparison to the untreated PCOS patients group (p=0.000).The results show a significant statistical differences when comparing interleukin-42 levels in the group of patients with PCOS patients treated with infertility drugs compared to the group of patients with Untreated PCOS patients group (p=0.000) or healthy women in the control group (p=0.002).The results indicated the significant positive correlations  when studying the relationship between Integrin and CLEC10A in the group PCOS patients treated with Metformin (r=0.841 at p=0.000) and in the group of untreated PCOS patients (r=0.854 at p=0.000), as well as healthy women (r=0.834 at p=0.000). According to the results, there is a strong negative correlation between Integrin and Interleukin-42 in PCOS patients treated with Metformin (r=0.871 at p=0.000), while; the significant positive correlations were observed when studying the relationship between Integrin and Interleukin-42 in the group of untreated PCOS patients (r=0.879 at p=0.000) and the group of healthy females (r=0.516 at p=0.040). The statistical analysis indicates a strong negative correlation between CLEC10A and interleukin-42 in PCOS patients treated with Metformin (r=0.859 at p=0.000), while changing in the opposite direction the results indicated to positive correlations between CLEC10A and interleukin-42 in the group untreated PCOS patients (r=0.619 at p=0.009), as well as, in the group of healthy females (r= 0.902 at p=0.000). The study showed the highest sensitivity (97%) and specificity (93%) for interleukin-42 were  recorded in the Metformin-treated group. The study revealed that integrin exhibited the highest individual sensitivity (96%) and specificity (80%) in the group of untreated PCOS patients. Conclusions: CLEC10A and interleukin-42 are promising tools for differentiating PCOS patients treated with Metformin and untreated PCOS patients.