Investigating Ziziphus jujuba Hydroalcoholic Extract, Metformin, and Myoinositol for Infertile PCOS Pregnancy Outcomes: Protocol for Randomized Control Trial

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.

Abstract

Introduction: Ziziphus jujuba, known for its rich content of flavonoids and antioxidant attributes, exhibits diverse effects on various health conditions. This study seeks to assess the effectiveness of Ziziphus jujuba as a supplementary treatment to enhance pregnancy outcomes in infertile individuals diagnosed with normogonadotropic normoestrogenic Polycystic Ovary Syndrome (PCOS) undergoing letrozole-induced ovulation induction. 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, Myoinositol, Metformin, or Placebo. Each group will consist of 49 individuals. Over 12 weeks, participants will receive their assigned intervention alongside letrozole-induced ovulation induction. Clinical and biochemical parameters relevant to pregnancy outcomes, emphasizing biochemical and clinical pregnancy, will be measured. Results: A total of 196 participants will be included in this study, with 49 individuals allocated to each group. It is anticipated that after the intervention, the Ziziphus jujuba group will demonstrate improved glucose metabolism and insulin resistance, as indicated by FBG and TyG indices, enhanced lipid profiles, and reduced inflammatory status compared to other groups. Consequently, these metabolic improvements are expected to result in a higher pregnancy rate in the Ziziphus jujuba group compared to the other study groups. Conclusion: This study seeks to explore the potential of Ziziphus jujuba as an adjunctive therapy in improving pregnancy outcomes among infertile individuals diagnosed with PCOS undergoing letrozole-induced ovulation induction. The findings may provide valuable insights into the role of herbal medicine in addressing fertility-related challenges associated with PCOS, potentially offering a cost-effective and accessible alternative to conventional pharmaceutical interventions.

Keywords

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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