FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea

Phase 3 Active not recruiting 33 enrolled Yale University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab Johns Hopkins University · collab University of Chicago · collab University of Illinois at Chicago · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to determine the effect of low caffeine green tea extract containing 45% epigallocatechin gallate (EGCG) on fibroids and subsequent pregnancy and live births in women seeking fertility treatment. The population will consist of 50 women desirous of conceiving, ages ≥18 to ≤40 years (at time of consent), and known to have class 2-6 fibroids, according to the FIGO staging system.

Timeline

Start: 2023-01-05
Primary completion: 2026-06-30
Completion: 2026-09-30

Publications

Al-Hendy A, Segars JH, Taylor HS, Gonzalez F, Siblini H, Zamah M, Alkelani H, Singh B, Flores VA, Christman GM, Johnson JJ, Huang H, Zhang H. Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids. BMJ Open. 2024 Jan 12;14(1):e078989. doi: 10.1136/bmjopen-2023-078989.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	green tea extract	Unknown	1650 mg	Oral

FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea

Summary

Timeline

Publications

Drugs

Indications