The effect of Vitex Agnus-Castus pill on follicles number and size in infertile women with polycystic ovary syndrome: A triple-blind placebo randomized clinical trial

Document Type : Original Article

Authors

1 M.Sc. student of Midwifery, Student Working Group of Social Development and Health Promotion Research Center, Faculty of Medicine, Gonabad University of Medical Sciences, Gonabad, Iran.

2 Assistant Professor, Department of Midwifery, Social Development and Health Promotion Research Center, Faculty of Medicine, Gonabad University of Medical Sciences, Gonabad, Iran.

3 Obstetrician, Shiraz University of Medical Sciences, Shiraz, Iran.

4 M.Sc. of Biostatistics, Research Center for Social Factors Affecting Health, school of Health, Gonabad University of Medical Sciences, Gonabad, Iran.

Abstract

Introduction: Polycystic ovary syndrome (PCOS) is the most common cause of ovulation disorder in women of childbearing age, with a prevalence of 20% worldwide. Due to the increasing tendency to use herbal medicines, this study was performed aimed to investigate the effect of Vitex Agnus-Castus pill on the number and size of follicles in infertile women with polycystic ovary syndrome.
Methods: This triple-blind clinical trial study was performed in 2020-2021 on 60 infertile women with polycystic ovary syndrome. Subjects were randomly assigned to the intervention (Vitex Agnus-Castus) and control (placebo) groups. The intervention group used two Vitex Agnus-Castus tablets and one Folic Acid daily and the control group used two placebo tablets and one Folic Acid tablet for two months. In the second month, in addition to the mentioned drugs, all participants from the third to the seventh day of menstruation used 2.5 mg Letrozole for five days and on the 13 day of the cycle, they referred for ultrasound. Data were analyzed using SPSS software (version 16) and Chi-square and Mann-Whitney tests. P<0.05 was considered statistically significant.
Results: After the intervention, the mean number of follicles in the Vitex Agnus-Castus group was significantly higher than the control group (2.73 ±0.90 vs. 2.06 ± 0.98, P = 0.008). Also in the Vitex Agnus-Castus group, the mean size of follicles was significantly higher than the control group (19.71± 1.98 vs. 17.73 ± 3.44, P = 0.009).
Conclusion: The use of Vitex Agnus-Castus tablets along with Letrozole in comparison with Letrozole alone can improve the quality of follicles.

Keywords

References

  1. Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, et al. Polycystic ovary syndrome. Nature reviews Disease primers 2016; 2(1):1-18.
  2. Naz MS, Tehrani FR, Majd HA, Ahmadi F, Ozgoli G, Fakari FR, et al. The prevalence of polycystic ovary syndrome in adolescents: A systematic review and meta-analysis. International Journal of Reproductive BioMedicine 2019; 17(8):533.
  3. Brassard M, AinMelk Y, Baillargeon JP. Basic infertility including polycystic ovary syndrome. Medical Clinics of North America 2008; 92(5):1163-92.
  4. Franik S, Eltrop SM, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for subfertile women with polycystic ovary syndrome. Cochrane Database of Systematic Reviews 2018(5).
  5. Neven AC, Laven J, Teede HJ, Boyle JA. A summary on polycystic ovary syndrome: diagnostic criteria, prevalence, clinical manifestations, and management according to the latest international guidelines. InSeminars in reproductive medicine 2018; 36(01):5-12.
  6. Mousavi P, Zaheri H, Najar S, Afshari P, Hayati F. Effect of vitagnus on Premenstrual syndrome. Iran J Obstet Gynecol Infertil 2015; 17(138):1-9.
  7. Mardani F, Hadizadeh-Talasaz F, Bahri N. Effect of medicinal plants on episiotomy wound healing in Iran: a systematic review study. Iran J Obstet Gynecol Infertil 2020; 23(5):79-94.
  8. Shahnazi M, Khalili AF, Hamdi K, Ghahremaninasab P. The Effects of Combined Low-Dose Oral Contraceptives and Vitex Agnus on the Improvement of Clinical and Paraclinical Parameters of Polycystic Ovarian Syndrome: A Triple-Blind, Randomized, Controlled Clinical Trial. Iranian Red Crescent Medical Journal 2016; 18(12).
  9. Seraji A, Salehi A, Momeni H, Karami A, Naeimi N. The Effects of Evening Primrose and Vitex Agnus on Pain Scale of the Women with Mastalgia a clinical Trial. Complementary Med J Faculty Nurs Medwifery 2013; 4(3):640-41.
  10. Heirati SF, Ozgoli G, KabodMehri R, Mojab F, Sahranavard S, Nasiri M. The 4-month effect of Vitex agnus-castus plant on sexual function of women of reproductive age: A clinical trial. Journal of Education and Health Promotion 2021; 10.
  11. Mirzaiinajmabdi KH. Effect of Vitex agnus-castus on sexual function in menopausal women. J Women's Health Care 2016; 5(4).
  12. Berger D, Schaffner W, Schrader E, Meier B, Brattström A. Efficacy of Vitex agnus castus L. extract Ze 440 in patients with pre-menstrual syndrome (PMS). Archives of gynecology and obstetrics 2000; 264(3):150-3.
  13. Arentz S, Abbott JA, Smith CA, Bensoussan A. Herbal medicine for the management of polycystic ovary syndrome (PCOS) and associated oligo/amenorrhoea and hyperandrogenism; a review of the laboratory evidence for effects with corroborative clinical findings. BMC complementary and alternative medicine 2014; 14(1):1-9.
  14. Niroumand M, Heydarpour F, Farzaei M. Pharmacological and therapeutic effects of Vitex agnus-castus L.: A review. Pharmacognosy Reviews 2018; 12(23).
  15. Sarwer DB, Durlak JA. A field trial of the effectiveness of behavioral treatment for sexual dysfunctions. Journal of Sex & Marital Therapy 1997; 23(2):87-97.
  16. Rafieian-Kopaei M, Movahedi M. Systematic review of premenstrual, postmenstrual and infertility disorders of Vitex agnus castus. Electronic physician 2017; 9(1):3685-9.
  17. Shahhosseini Z, Amin GH, Salehi Sormaghi MH, Danesh MA, Abedian K. Clinical evaluation of anti-dysmenorrhea vitagnus. J Mazandaran Uni Med Sci 2006; 15(50):15-21.
  18. Hobbs C. Vitex: The women’s herb. 2nd Summertown: Healty Living Publication; 2003. p. 43-5.
  19. Hamza AH, AlBishri WM, Alfaris MH. Effect of Vitex agnus-castus plant extract on polycystic ovary syndrome complications in experimental rat model. Asian Pacific Journal of Reproduction 2019; 8(2):63.
  20. Hossein-Rashidi B, Nemati M. Effects of Vitex agnus-castus extract on the secretory function of pituitary-gonadal axis and pregnancy rate in patients with premature ovarian aging (POA). Journal of herbal medicine 2017; 10:24-30.
  21. Claudia D, Coon T, Max PH. Vitex agnus castus: A Systematic Review of Adverse Events. Drug Safety 2005; 28:319-2.
  22. Ghahremaninasab P. Comparing Effect of Oral Contraceptive LD and Vitex Agnus in Improved Clinical and Paraclinical Parameters of Poly Cystic Ovarian Syndrome (PCOS): A Triple Blind Randomized Clinical Controlled Trial (Doctoral dissertation, Tabriz University of Medical Sciences, School of Nursing and Midwifery; 2016.
  23. Allahtavakoli M, Honari N, Pourabolli I, Arababadi MK, Ghafarian H, Roohbakhsh A, et al. Vitex agnus castus extract improves learning and memory and increases the transcription of estrogen receptor α in hippocampus of ovariectomized rats. Basic and clinical neuroscience 2015; 6(3):185.
  24. Shahhosseini Z, Amin GH, Danesh MM, Abedian K. Double blind study of anti primary dysmenorrhea effects of vitagnus. Journal of Mazandaran University of Medical Sciences 2006; 15(50):15-21.
  25. Momeni H, Salehi A, Seraji A. Comparing the effect of Vitex Agnus Castus and Evening Primrose oil on depression. Modern Care Journal 2013; 10(2):149-56.
  26. Jelodar GH, Karami E. Effect of hydroalcoholic extract of vitex agnus-castus fruit on ovarian histology in rat with induced Polycystic Ovary Syndrome (PCOS). Journal of BABOL University of Medical Sciences 2013; 15(3):96-102.
  27. Chen SN, Friesen JB, Webster D, Nikolic D, van Breemen RB, Wang ZJ, et al. Phytoconstituents from Vitex agnus-castus fruits. Fitoterapia 2011; 82(4):528-33.
  28. Elshaer SS, Anwar HM, Zohni MS. Hormonal profile amelioration by the mixture of Vitex agnus castus and metformin on polycystic ovary remedy. World J Pharm Res 2015; 4:39-51.
  29. Ghorbani T, Karimi A, Najafi G, Besharti M, Sharafi M. Therapeutic effects of Vitex (Vitagnus castus) extract on in vitro maturation and fertilization of oocytes in mice affected by polycystic ovary syndrome. Veterinary Clinical Pathology The Quarterly Scientific Journal 2020; 14(54):101-13.
  30. Hosseinzadeh Sahafi H, Talebzadeh SA, Naji T. The role‌‌ of different concentration of Vitex agnus-castus on control of ripeness of gonad of Carassius auratus. Journal of Aquaculture Development 2018; 12(3):63-74.
  31. Bergmann J, Luft B, Boehmann S, Runnebaum B, Gerhard I. The efficacy of the complex medication Phyto-Hypophyson L in female, hormone-related sterility. A randomized, placebo-controlled clinical double-blind study. Forschende Komplementarmedizin und klassische Naturheilkunde= Research in complementary and natural classical medicine 2000; 7(4):190-9.
The Iranian Journal of Obstetrics, Gynecology and Infertility
Volume 25, Issue 6
August 2022
Pages 98-106

Files

Share

How to cite

Statistics