# Reproductive Medicine Collaborative Consortium: a randomized placebo-controlled trial of EGCG to improve fertility in women with uterine fibroids-  Application 4/4

> **NIH NIH R01** · YALE UNIVERSITY · 2022 · $344,742

## Abstract

Abstract
Uterine leiomyomas (fibroids) are the most important neoplastic threat to women's health worldwide,
disproportionately affect women of color and are a significant cause of infertility. Intramural and submucosal
fibroids reduce the likelihood of pregnancy compared to unaffected women. Surgical removal of fibroids is
afflicted with high recurrence rates and frequent postoperative consequences such as adhesions. There is a
critical need for innovative effective, non-hormonal, non-surgical fertility treatment options for women with
fibroids that may distort the uterine cavity. Our long-term goal is to develop novel non-hormonal treatments for
uterine fibroids. Green tea catechins, such as epigallocatechin gallate (EGCG) is safe during conception and
pregnancy. EGCG inhibits key pathways of tumor growth by modulating signaling pathways involved in cell
proliferation, transformation, apoptosis and inflammation. Our team evaluated the efficacy and safety of EGCG
in women with symptomatic uterine fibroids in a double-blinded, placebo-controlled randomized clinical trial. In
the placebo group, fibroid volume increased; however, patients randomized to EGCG (800 mg/day) showed
significant reduction in total fibroid volume. These data indicate that EGCG reduces fibroid size and represents
a possible non-hormonal treatment for women with fibroids pursuing pregnancy. The objective of this study is
to conduct a randomized clinical trial to determine the effect of EGCG on fibroids and subsequent pregnancy in
women seeking fertility treatment. Our central hypothesis is that EGCG will reduce fibroid size and increase the
likelihood of pregnancy. To test this hypothesis, we propose a placebo-controlled clinical trial to evaluate live
birth outcomes for women with unexplained infertility who have uterine fibroids. Subjects will be randomized to
either oral EGCG vs. placebo for up to 7 months with a 3-month run-in period followed by ovarian stimulation
and intrauterine insemination for up to 4 cycles. We will determine the clinical efficacy of EGCG in a
randomized study in 654 women pursuing fertility care; and determine pregnancy outcomes in women seeking
fertility care treated with EGCG compared to placebo. To meet recruitment goals, the PIs have formed a
consortium. Yale will serve as the data coordinating center and a clinical site, Hopkins will coordinate the single
IRB and be a clinical site. Investigators at University of Illinois at Chicago have extensive experience with
EGCG and clinical trials and will serve as lead PI. Investigators at the University of Florida have special
expertise in clinical trials for fibroids and infertility treatment with prior experience in the Reproductive Medicine
Network. Each institution has high volume of eligible patients and an excellent fertility center. The proposed
research will have an immense positive impact on women with uterine fibroids that are seeking fertility care.

## Key facts

- **NIH application ID:** 10477364
- **Project number:** 5R01HD100369-04
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Hugh Smith Taylor
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $344,742
- **Award type:** 5
- **Project period:** 2019-09-26 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10477364

## Citation

> US National Institutes of Health, RePORTER application 10477364, Reproductive Medicine Collaborative Consortium: a randomized placebo-controlled trial of EGCG to improve fertility in women with uterine fibroids-  Application 4/4 (5R01HD100369-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10477364. Licensed CC0.

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