RecruitingPhase 3NCT05364008

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

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

Sponsor

Yale University

Enrollment

50 participants

Start Date

Jan 5, 2023

Study Type

INTERVENTIONAL

Conditions

Leiomyoma, Uterine

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a natural compound found in green tea called EGCG (epigallocatechin gallate) can shrink uterine fibroids and improve fertility in women with unexplained infertility. **You may be eligible if...** - You are a woman between 18 and 40 years old - You have intramural or subserosal uterine fibroids (at least one measuring 1 cm or more) - You have been trying to conceive for at least 6 months (or 12 months if under 35) without success - You ovulate regularly (at least 9 periods per year) **You may NOT be eligible if...** - You have known causes for infertility other than fibroids (e.g., blocked tubes, hormonal issues, male factor infertility) - You have submucosal fibroids only (type 0 or 1 without additional types) - You are currently using hormonal contraception or fertility treatments - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGreen Tea Extract

Green tea extract 1650 mg/day (45% EGCG) along with ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 4 cycles.

OTHERPlacebo

Placebo 1650 mg/day along with ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 4 cycles.