Study Protocol: Evaluating the Impact of Diabetic Medications on Semen Quality: A Comparative Analysis of Diabetic Patients and Nondiabetic Controls with Correlation to Fertility Potential.

Abstract

Background: Infertility is a growing global concern, with diabetes emerging as a significant contributor to male reproductive dysfunction. Diabetes negatively affects sperm quality by altering hormonal balance, increasing oxidative stress, and impairing sperm motility, morphology, and count. While previous studies have established a link between diabetes and infertility, limited research has focused on the effects of diabetic medications on sperm parameters and fertility outcomes.

Objectives: This study aims to evaluate the impact of diabetic medications on semen quality by comparing diabetic patients receiving pharmacological treatment, untreated diabetic patients, and nondiabetic controls. The research will focus on assessing sperm count, motility, morphology, and oxidative stress markers to determine how different diabetes management strategies influence male fertility.

Methodology: A comparative observational study will be conducted over 6 months at Wardha Test Tube Baby Centre, AVBRH, Sawangi Meghe, Wardha. Male participants diagnosed with diabetes and experiencing infertility will be categorized into four groups: (1) Type 1 diabetes patients on insulin therapy, (2) Type 2 diabetes patients on oral medications, (3) diabetic patients without pharmacological treatment, and (4) nondiabetic controls. A semen analysis will be performed using standard laboratory techniques to evaluate sperm parameters and oxidative stress levels. ANOVA and correlation tests will be used for statistical analysis.

Expected results: This study aims to provide detailed insights into how different diabetes treatments impact sperm vitality, helping identify the best options for fertility preservation. By generating comparative data on the effects of insulin and oral medications on sperm quality and fertility, the findings will guide clinicians in recommending the most suitable treatment for diabetic men concerned about reproduction. Additionally, understanding how sperm quality changes over time in diabetic men will help determine critical periods for intervention based on disease duration and treatment type. A comparison between treated diabetic patients and nondiabetic controls will further clarify the effects of diabetic medications on sperm health.

Study implications: This study will help evaluate how different diabetes treatments, such as insulin and oral medications, affect sperm health. Understanding these effects can lead to personalized treatment approaches that reduce the negative impact on male fertility. Additionally, the research will provide valuable insights into the complex relationship between diabetes, its management, and male reproductive health. This knowledge will help healthcare professionals develop better strategies for managing infertility in diabetic men, ultimately improving outcomes for couples struggling with conception.