~17 spots leftby Jun 2026

Fibroids & Infertility

(FRIEND Trial)

Recruiting at 3 trial locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Yale University
Must not be taking: Depo-progestins, Hormonal implants
Disqualifiers: Pregnancy, Diabetes, Heart disease, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests if a low caffeine green tea extract with high EGCG can help women aged 18-40 with fibroids get pregnant. The EGCG may shrink fibroids and improve the uterus lining, increasing pregnancy chances. EGCG, a major component of green tea, has been studied for its potential benefits in reducing uterine fibroids and improving reproductive health.

Will I have to stop taking my current medications?

The trial requires that participants not take any medications that could interfere with the study. If you are on depo-progestins or hormonal implants, a two-month period without these medications is needed before screening. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the treatment Green Tea Extract for uterine fibroids and infertility?

Research shows that Epigallocatechin Gallate (EGCG), a component of green tea extract, can shrink uterine fibroids and improve symptoms of benign gynecological disorders. It has been studied for its potential to reduce fibroid size and alleviate symptoms, although its role in treating infertility remains controversial.12345

Is green tea extract safe for humans, particularly for women with uterine fibroids?

Research shows that taking 800 mg of green tea extract (EGCG) daily is generally safe for women, as it does not cause liver damage or affect folate levels. This suggests that green tea extract is well-tolerated in humans.12356

How does the drug Green Tea Extract (EGCG) differ from other treatments for uterine fibroids and infertility?

Green Tea Extract, specifically its component EGCG, is unique because it works by reducing the size of uterine fibroids through anti-fibrotic, anti-angiogenic (preventing new blood vessel formation), and pro-apoptotic (promoting cell death) mechanisms, which are different from traditional surgical or hormonal treatments. Additionally, it is a natural compound with antioxidant properties, offering a non-invasive alternative with fewer side effects.12357

Research Team

DW

David Weinberg, PhD

Principal Investigator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria

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.

Inclusion Criteria

I have fibroids of specific types and sizes according to FIGO classifications.
At least one open fallopian tube confirmed by hysterosalpingography (HSG), sonohysterography, or laparoscopy/hysteroscopy in the last three years preceding enrollment into the study. An uncomplicated intrauterine non-IVF pregnancy and uncomplicated delivery and postpartum course resulting in live birth within the last three years will also serve as sufficient evidence of a patent tube and normal uterine cavity as long as the participant did not have, during the pregnancy or subsequently, risk factors for Asherman's syndrome or tubal disease or other disorder leading to an increased suspicion for intrauterine abnormality or tubal occlusion.
At least one open fallopian tube confirmed by hysterosalpingography (HSG), sonohysterography, or laparoscopy/hysteroscopy in the last three years preceding enrollment into the study. An uncomplicated intrauterine non-IVF pregnancy and uncomplicated delivery and postpartum course resulting in live birth within the last three years will also serve as sufficient evidence of a patent tube and normal uterine cavity as long as the participant did not have, during the pregnancy or subsequently, risk factors for Asherman's syndrome or tubal disease or other disorder leading to an increased suspicion for intrauterine abnormality or tubal occlusion.
See 9 more

Exclusion Criteria

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.
See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low caffeine green tea extract or placebo along with Clomiphene citrate-intrauterine insemination (CC-IUI) cycle, up to 4 cycles if no pregnancy is achieved

Up to 4 cycles
Regular visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of conception and live birth outcomes

Up to 15 months

Treatment Details

Interventions

  • Green Tea Extract (Polyphenol)
  • Placebo (Other)
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

University of Illinois at Chicago

Collaborator

Trials
653
Recruited
1,574,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

University of Chicago

Collaborator

Trials
1,086
Recruited
844,000+

Findings from Research

Epigallocatechin gallate (EGCG) from green tea significantly inhibits the growth of cultured human leiomyoma cells (HuLM) in a dose- and time-dependent manner, suggesting its potential as a treatment for uterine fibroids.
EGCG treatment not only induces apoptosis in HuLM cells but also alters gene expression related to key signaling pathways, including up-regulating TGF-β and stress pathways while inhibiting survival and inflammatory pathways.
Antiproliferative and proapoptotic effects of epigallocatechin gallate on human leiomyoma cells.Zhang, D., Al-Hendy, M., Richard-Davis, G., et al.[2021]
Green tea, particularly its main component EGCG, has shown potential therapeutic benefits in treating benign gynecological disorders, such as alleviating symptoms of uterine fibroids and improving endometriosis through various cellular mechanisms.
EGCG can also help reduce pain associated with dysmenorrhea and adenomyosis, and while its role in infertility is debated, it may provide symptomatic relief during menopause and for conditions like polycystic ovary syndrome (PCOS).
Green Tea and Benign Gynecologic Disorders: A New Trick for An Old Beverage?Hazimeh, D., Massoud, G., Parish, M., et al.[2023]
The combination of Crila and the green tea extract EGCG showed synergistic effects in inhibiting the growth of human uterine fibroid cells, suggesting a more effective treatment than using either compound alone.
This growth inhibition was linked to reduced cell proliferation rather than increased cell death, indicating that these natural compounds could serve as a safe and cost-effective alternative to hormonal therapies for treating uterine fibroids.
The combination of natural compounds Crila and epigallocatechin gallate showed enhanced antiproliferative effects on human uterine fibroid cells compared with single treatments.Bai, T., Ali, M., Somers, B., et al.[2023]

References

Antiproliferative and proapoptotic effects of epigallocatechin gallate on human leiomyoma cells. [2021]
Green Tea and Benign Gynecologic Disorders: A New Trick for An Old Beverage? [2023]
The combination of natural compounds Crila and epigallocatechin gallate showed enhanced antiproliferative effects on human uterine fibroid cells compared with single treatments. [2023]
Green tea extract inhibition of human leiomyoma cell proliferation is mediated via catechol-O-methyltransferase. [2021]
Assessing the Hepatic Safety of Epigallocatechin Gallate (EGCG) in Reproductive-Aged Women. [2023]
Effects of epigallocatechin gallate-enriched green tea extract capsules in uterine myomas: results of an observational study. [2021]
Biological and Mechanistic Characterization of Novel Prodrugs of Green Tea Polyphenol Epigallocatechin Gallate Analogs in Human Leiomyoma Cell Lines. [2018]