Investigating the Effects of Ziziphus Jujuba Extract, Metformin, and Myoinositol on Pregnancy Outcomes and Metabolic Parameters in PCOS Women Undergoing Ovulation Induction: A Randomized Controlled Trial Protocol

Articles in Press

Document Type : Protocol Study

Authors

1 Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

2 Women's Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

3 Pharmacological Research Center of Medicinal Plants, Mashhad University of Medical Sciences, Mashhad, Iran.

4 Department of Community Medicine and Public Health, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

5 Research Committee Student, School of Dentistry, Mashhad University of Medical Science, Mashhad, Iran.

6 Metabolic Syndrome Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Abstract

Introduction: Ziziphus jujuba, a flavonoids rich plant and is renowned for its potent antioxidant properties with diverse health benefits across various conditions. This study aims to evaluate the efficacy of Ziziphus jujuba as an adjunct therapy for improving pregnancy outcomes in infertile women diagnosed with normogonadotropic normoestrogenic Polycystic Ovary Syndrome (PCOS) undergoing ovulation induction with letrozole. Methods: A total of 196 participants diagnosed with PCOS and infertility will be recruited from the Milad Infertility Center in Mashhad, Iran. Participants will be randomly assigned to one of four groups: Ziziphus jujuba, Myoinositol, Metformin, or Placebo, with each group consisting of 49 individuals. Over 12 weeks, participants will receive their allocated intervention in conjunction with letrozole for ovulation induction. Clinical and biochemical parameters associated with pregnancy outcomes, including biochemical and clinical pregnancy rates, will be assessed. Results: A total of 196 participants will be included in this study, with 49 participants assigned to each group. It is hypothesized that the Ziziphus jujuba group will exhibit improved glucose metabolism and reduced insulin resistance, as measured by fasting blood glucose (FBG) and triglyceride-glucose (TyG) indices, along with enhanced lipid profiles and reduced inflammatory markers, compared to the other groups. These anticipated metabolic improvements are expected to lead to a higher pregnancy rate in the Ziziphus jujuba group than in the different study groups. Conclusion: This study aims to investigate the potential of Ziziphus jujuba as an adjunctive therapy to improve pregnancy outcomes in infertile women diagnosed with PCOS undergoing letrozole-induced ovulation induction. The findings are expected to provide valuable insights into the role of herbal medicine in addressing fertility challenges associated with PCOS, potentially presenting a cost-effective and accessible alternative to conventional pharmaceutical treatments.

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Main Subjects

References

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Journal of Nutrition,Fasting and Health

Articles in Press, Accepted Manuscript
Available Online from 20 January 2025

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History

  • Receive Date: 25 December 2024
  • Revise Date: 15 January 2025
  • Accept Date: 19 January 2025

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