FATIMA Trial: EGCG and Vitamin D3 for Prevention of Fibroid Recurrence

Summary

The aim of this randomized controlled clinical trial is to evaluate the efficacy of green tea (EGCG) and vitamin D3 supplementation in preventing uterine fibroid recurrence following fibroid removal.

Timeline

Start

2026-08-22

Primary completion

2029-08-22

Completion

2029-12-22

Publications

• Background Sharan C, Halder SK, Thota C, Jaleel T, Nair S, Al-Hendy A. Vitamin D inhibits proliferation of human uterine leiomyoma cells via catechol-O-methyltransferase. Fertil Steril. 2011 Jan;95(1):247-53. doi: 10.1016/j.fertnstert.2010.07.1041. Epub 2010 Aug 23.
• Background Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, Critchley HOD, Li Y, McKain L, Arjona Ferreira JC, Langenberg AGM, Wagman RB, Stewart EA. Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy. N Engl J Med. 2021 Feb 18;384(7):630-642. doi: 10.1056/NEJMoa2008283.
• Background Halder SK, Goodwin JS, Al-Hendy A. 1,25-Dihydroxyvitamin D3 reduces TGF-beta3-induced fibrosis-related gene expression in human uterine leiomyoma cells. J Clin Endocrinol Metab. 2011 Apr;96(4):E754-62. doi: 10.1210/jc.2010-2131. Epub 2011 Feb 2.
• Background Vafaei S, Ciebiera M, Omran MM, Ghasroldasht MM, Yang Q, Leake T, Wolfe R, Ali M, Al-Hendy A. Evidence-Based Approach for Secondary Prevention of Uterine Fibroids (The ESCAPE Approach). Int J Mol Sci. 2023 Nov 4;24(21):15972. doi: 10.3390/ijms242115972.
• Background Roshdy E, Rajaratnam V, Maitra S, Sabry M, Allah AS, Al-Hendy A. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study. Int J Womens Health. 2013 Aug 7;5:477-86. doi: 10.2147/IJWH.S41021. eCollection 2013.
• Background Halder SK, Sharan C, Al-Hendy A. 1,25-dihydroxyvitamin D3 treatment shrinks uterine leiomyoma tumors in the Eker rat model. Biol Reprod. 2012 Apr 19;86(4):116. doi: 10.1095/biolreprod.111.098145. Print 2012 Apr.
• Background Zhang D, Al-Hendy M, Richard-Davis G, Montgomery-Rice V, Sharan C, Rajaratnam V, Khurana A, Al-Hendy A. Green tea extract inhibits proliferation of uterine leiomyoma cells in vitro and in nude mice. Am J Obstet Gynecol. 2010 Mar;202(3):289.e1-9. doi: 10.1016/j.ajog.2009.10.885. Epub 2010 Jan 13.
• Background Zhang D, Al-Hendy M, Richard-Davis G, Montgomery-Rice V, Rajaratnam V, Al-Hendy A. Antiproliferative and proapoptotic effects of epigallocatechin gallate on human leiomyoma cells. Fertil Steril. 2010 Oct;94(5):1887-93. doi: 10.1016/j.fertnstert.2009.08.065. Epub 2009 Oct 12.
• Background Zhang D, Rajaratnam V, Al-Hendy O, Halder S, Al-Hendy A. Green tea extract inhibition of human leiomyoma cell proliferation is mediated via catechol-O-methyltransferase. Gynecol Obstet Invest. 2014;78(2):109-18. doi: 10.1159/000363410. Epub 2014 Jun 18.

Drugs

Indications