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Polyphenol

Fibroids & Infertility (FRIEND Trial)

Phase 3
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intramural fibroids and/or subserosal fibroids that meet the criteria for FIGO types 2-6; at least one fibroid with an average diameter of at least 1 cm in three dimensions. Participants with multiple fibroids including FIGO type 0 and type 1 will be allowed only in combination with additional fibroids type 2-6.
Women ≥18 to ≤40 years of age, with six months or more infertility history, desirous of conceiving, regularly ovulating (defined as 9 or more menses per year), at initiation of participation. Women < 35 years of age must have at least 12 months of infertility history.
Timeline
Screening 0.5 days
Treatment 3 months
Follow Up 3 months
Awards & highlights

Summary

This trial will test whether low caffeine green tea extract can help with fibroids and getting pregnant.

Who is the study for?
This trial is for women aged 18-40 with a desire to conceive, who have been infertile for at least six months and have certain types of uterine fibroids (FIGO types 2-6). They must be regularly ovulating, have at least one open fallopian tube, and their male partner should have a sufficient sperm count. Women can't join if they've had severe endometriosis, unexplained bleeding, alcohol abuse issues or a history of blood clots.Check my eligibility
What is being tested?
The study aims to see if taking green tea extract containing epigallocatechin gallate (EGCG) affects the size of fibroids in the uterus and improves chances of pregnancy and live births compared to those taking a placebo. The trial involves 200 women seeking fertility treatment.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects from green tea extract could include stomach upset or constipation. High doses might cause more serious problems like liver damage but are unlikely given careful monitoring in the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have fibroids of specific types and sizes according to FIGO classifications.
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I am a woman aged 18-40, trying to conceive for 6+ months, with regular periods.
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My male partner has a sperm count of at least 5 million motile sperm/ml in the past year.
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I agree not to consume any green tea products during the study.

Timeline

Screening ~ 0.5 days
Treatment ~ 3 months
Follow Up ~3 months
This trial's timeline: 0.5 days for screening, 3 months for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative live birth rate.
Secondary outcome measures
The change of fibroid symptom severity score
The change of fibroid volume
The change of health-related quality-of-life questionnaire score
+3 more

Side effects data

From 2011 Phase 2 trial • 98 Patients • NCT00303823
32%
Nausea
26%
Headache
14%
Dizziness
12%
Stomach pain
12%
Cervicitis
10%
ALT increased
8%
Sore throat
8%
Fatigue
8%
AST increased
8%
Other respiratory disorders
6%
Sinusitis
6%
Back pain
6%
Irregular menses
6%
Vomiting
4%
Abdomen pain
4%
Constipation
2%
Diarrhea
2%
Other reproductive system disorders
2%
Other pain
2%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Polyphenon E
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Green tea extract containing 45% epigallocatechin gallate (EGCG)Experimental Treatment1 Intervention
Low caffeine green tea extract (1650mg in 6 capsules) taken orally on a daily basis (QD) along with Clomiphene citrate-intrauterine insemination (CC_IUI) cycle, up to 4 cycles if no pregnancy is achieved, participant will stop green tea if she becomes pregnant
Group II: PlaceboPlacebo Group1 Intervention
Placebo (1650mg in 6 capsules) matched (smell, taste, color, texture) capsules taken orally on a daily basis (QD) along with Clomiphene citrate-intrauterine insemination (CC_IUI) cycle, up to 4 cycles if no pregnancy is achieved, participant will stop placebo if she becomes pregnant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Green Tea Extract
2019
N/A
~40

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for uterine fibroids often focus on reducing inflammation and inhibiting cell proliferation. Green Tea Extract (EGCG) is being studied for its anti-inflammatory and anti-proliferative properties, which can help reduce the size and symptoms of fibroids. These mechanisms are crucial as they target the underlying processes that contribute to fibroid growth and symptom severity. By reducing inflammation, these treatments can alleviate pain and discomfort, while anti-proliferative effects can limit the growth and recurrence of fibroids, offering a non-surgical option for management.
Randomized double-blind trial comparing low dose and conventional dose of a modified traditional herbal formula Guizhi Fuling Wan in women with symptomatic uterine fibroids.Adjuvant therapy of Chinese herbal medicine for the treatment of adenomyosis: A protocol for systematic review.Selection and efficacy of self-management strategies for dysmenorrhea in young Taiwanese women.

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoOTHER
618 Previous Clinical Trials
1,563,838 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,285 Previous Clinical Trials
14,842,865 Total Patients Enrolled
Yale UniversityLead Sponsor
1,874 Previous Clinical Trials
2,953,356 Total Patients Enrolled

Media Library

Green Tea Extract (Polyphenol) Clinical Trial Eligibility Overview. Trial Name: NCT05364008 — Phase 3
Uterine Fibroids Research Study Groups: Green tea extract containing 45% epigallocatechin gallate (EGCG), Placebo
Uterine Fibroids Clinical Trial 2023: Green Tea Extract Highlights & Side Effects. Trial Name: NCT05364008 — Phase 3
Green Tea Extract (Polyphenol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364008 — Phase 3
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