🏛️ Verified NIH Record • Updated 2026-08-18

FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea (NCT05364008)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Yale University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (26 items).

Location: Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences — New Haven, Connecticut

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participants with only intracavity uterine fibroid (FIGO Type 0 or Type 1) when not in combination with other types of fibroids (FIGO type 2-6).
  • Currently pregnant.
  • Clinical intrauterine miscarriages prior to initiating participation: participants must wait 3 months. No exclusion for biochemical pregnancies.
  • Subjects using Green Tea/EGCG within 2 weeks prior to study enrollment. Matcha (Japanese green tea), maca powder, green tea beverages and all other forms of green tea require a 2-week wash-out.
  • Undiagnosed abnormal uterine bleeding.
  • Suspicious ovarian mass.
  • Participants on depo-progestins, or hormonal implants (including Implanon). A two-month washout period will be required prior to screening for participants on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially when the implants are still in place.
  • Known 21-hydroxylase deficiency or other enzyme defects causing congenital adrenal hyperplasia.
  • Uncontrolled diabetes with HbA1c \> 6.5%
  • Known significant anemia (Hemoglobin \<8 g/dL).
  • History of deep venous thrombosis, pulmonary embolus, or cerebrovascular event.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

  • Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences — New Haven, Connecticut
  • University of Illinois at Chicago College of Medicine — Chicago, Illinois
  • University of Chicago, Department of Obstetrics and Gynecology — Chicago, Illinois
  • Johns Hopkins, Division of Reproductive Science and Women's Health Research — Baltimore, Maryland

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗