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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
FRIEND Trial 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.
FRIEND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have fibroids of specific types and sizes according to FIGO classifications.
Select...
I am a woman aged 18-40, trying to conceive for 6+ months, with regular periods.
Select...
My male partner has a sperm count of at least 5 million motile sperm/ml in the past year.
Select...
I agree not to consume any green tea products during the study.
FRIEND Trial Timeline
Screening ~ 0.5 days8 visits
Treatment ~ 3 months3 visits
Follow Up ~ 3 months1 visit
Screening ~ 0.5 days
Treatment ~ 3 months
Follow Up ~3 months
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 moreSide effects data
From 2011 Phase 2 trial • 98 Patients • NCT0030382332%
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
FRIEND 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
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityOTHER
2,263 Previous Clinical Trials
14,822,965 Total Patients Enrolled
University of Illinois at ChicagoOTHER
609 Previous Clinical Trials
1,559,109 Total Patients Enrolled
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,241 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have fibroids of specific types and sizes according to FIGO classifications.I have been diagnosed with Cushing's disease.You regularly drink too much alcohol or have a history of binge drinking.I have had a blood clot in my veins, lungs, or a stroke.My endometriosis is severe (stage 3 or 4) with cysts larger than 3cm.I have unexplained bleeding from my uterus.I have fibroids of specific types that are at least 1 cm big.I am a woman aged 18-40, wanting to conceive, with a history of infertility for 6+ months and have regular periods.Patients with AMH ≥ 1.0 ng/ml are eligible for the study.I agree not to consume any green tea products during the study.My male partner has a sperm count of at least 5 million motile sperm/ml in the past year.I am a woman aged 18-40, trying to conceive for 6+ months, with regular periods.My endometriosis is not severe.
Research Study Groups:
This trial has the following groups:- Group 1: Green tea extract containing 45% epigallocatechin gallate (EGCG)
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 0.5 Days to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age limit for this trial extend beyond 75 years old?
"This particular clinical trial is only for patients that fall between the ages of 18 and 40. There are 16 other medical studies available for minors and 56 trials open to seniors."
Answered by AI
How many people are enrolled in this trial?
"In order to move forward, this study requires 200 individuals who fit the pre-determined eligibility criteria. Currently, patients can participate at University of Chicago and Department of Obstetrics and Gynecology in Chicago, Illinois or Johns Hopkins, Division of Reproductive Science and Women's Health Research in Baltimore, Maryland."
Answered by AI
Has Green Tea Extract been cleared for use by the FDA?
"Green Tea Extract has undergone multiple rounds of testing with some data supporting its efficacy, so it received a score of 3."
Answered by AI
Are we currently looking for more individuals to participate in this clinical trial?
"That is correct. The clinical trial is currently looking for 200 patients between the 4 sites that are hosting the study. According to the data on clinicaltrials.gov, the trial was initially posted on 10/1/2022 and was last updated on 9/7/2022."
Answered by AI
Who meets the qualifications for participating in this research?
"This study is looking for 200 participants with fibroid tumors aged 18 and 40. Most notably, patients must meet the following criteria: 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., Minimal, mild, or moderate endometriosis (per PI discretion)., Intramural fibroids and/or subserosal fibroids that meet the criteria for FIGO types"
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
Georgia
New York
Other
How old are they?
18 - 65
What site did they apply to?
University of Illinois at Chicago College of Medicine
University of Chicago, Department of Obstetrics and Gynecology
Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
Ive been trying to conceive for 10 years now and I see tis as my last opportunity.
PatientReceived 2+ prior treatments
I am a 30 year old woman and desperately want to experience the joy of being a mother. Me and my partner were trying to conceive for almost 3 years now. I don't understand the reason why am i not getting pregnant when I ovulate and have a regular monthly period. One i notice with my period though is that it only lasts for 2-3 days and only with mild flow.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
I am 46 years old can I still try?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences: < 24 hours
Average response time
- < 1 Day
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