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

• Status: Not yet recruiting
• Trial end date: 2025-06-15
• Target enrollment: 0
• Participant gender: Female

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 200 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Johns Hopkins University; University of Chicago; University of Illinois at Chicago
• Treatments: Epigallocatechin gallate

Criteria

Inclusion Criteria:

1. 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.

2. 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.

3. Baseline AMH ≥ 1.0 ng/ml.

4. 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.

5. Evidence of ovarian function/reserve as assessed by day 3 (+/-2 days) FSH ≤12 IU/L within one year prior to study initiation.

6. Normal or corrected thyroid function within one year of study initiation.

7. Normal prolactin level within one year of study initiation.

8. In general, good health as assessed by PI, not taking any medications which could interfere with the study (e.g., FSH, insulin sensitizers).

9. Ability to have inseminations following hCG administration.

10. If applicable, the study participant will inform their partner of trial participation.

11. Male partner with total motile sperm in the ejaculate of at least 5 million sperm/ml, within one year of study initiation.

Participant agreement to abstain from use of green tea products in any form during course of study participation in trial.

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Exclusion Criteria:

1. 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).

2. Currently pregnant or successful pregnancies within 12 months of initiating participation. Clinical intrauterine miscarriages prior to initiating participation: participants over 35 must wait 3 months, while participants under 35 must wait 6 months. No exclusion for biochemical pregnancies.

3. 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. Patients with a detectable EGCG level at the screening visit will be excluded.

4. Undiagnosed abnormal uterine bleeding.

5. Suspicious ovarian mass.

6. Participants on oral contraceptives, 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. A one-month washout will be required for participants on oral cyclic progestins.

7. Known 21-hydroxylase deficiency or other enzyme defects causing congenital adrenal hyperplasia.

8. Type I or Type II diabetes mellitus.

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