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

Study acronym: FRIEND
StatusActive, Not Recruiting
PhasePhase 3
Started2023-01-05
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
Study Status v13
Primary completion dateestimated 2026-06-30→confirmed 2026-07-03
2026-03-18
Recruiting→Active, Not Recruiting Study Status, Oversight, Study Design, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 50→confirmed 33
Study sitesdetails revised at 4 of 4 sites
2025-07-21
Study Status v11
Re-verified, no change to tracked fields
2025-03-04
Study Status, Oversight, Contacts/Locations v10
Primary completion date2025-12-30→2026-06-30
Completion date2025-12-30→2026-09-30
Study sitescontacts updated at 2 of 4 sites
2024-05-13
Study Status, Study Description, Study Design, Eligibility v9
Primary completion date2024-09-30→2025-12-30
Completion date2024-09-30→2025-12-30
Enrollment target200→50
Eligibility criteriarevised
[...] tal adrenal hyperplasia. Uncontrolled diabetes with HbA1c > 86.05% Known significant anemia (Hemoglobin <8 g/dL). History of [...]
Study description-8 characters
[...] cal trial of low caffeine green tea extract versus placebo. Two hundredFifty (20050) participants will be randomized via computer-generated ran [...] will be on a 3:1 basis in favor of green tea extract, thus 15037 participants will be assigned to the first arm (green tea extract) and 5013 participants to the second arm (placebo). Clomiphene citrat [...]
Show 8 earlier versions
2023-05-24
Study Status, Arms and Interventions, Eligibility v8
Eligibility criteriarevised
[...] e at least 12 months of infertility history. Baseline AMH ≥ 10.07 ng/ml. At least one open fallopian tube confirmed by hyster [...]
2023-01-12
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v7
Start dateestimated 2023-01→confirmed 2023-01-05
Eligibility criteria-534 characters
[...] suspicion for intrauterine abnormality or tubal occlusion. Minimal, mild, or moderate endometriosis (per PI discretion). Evidence of ovarian function/reserve as assessed by day 3 (+ [...] ys) FSH ≤12 IU/L within one year prior to study initiation. Normal or corrected thyroid function within one year of study initiation. Normal prolactin level within one year of study initiation. In general, good health as assessed by PI, not taking any medications which could interfere with the study (e.g., FSH,). Ability to have inseminations following hCG administration [...] other types of fibroids (FIGO type 2-6). Cur [...]
Secondary endpointsdetails revised at 6 of 6 entries
Study description-195 characters
[...] ral low caffeine green tea extract (1650mg/day) vs. placebo for up to 7 months with a 3-month run in period followed byalong ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 34 cycles. Endpoints Primary Endpoint: - Our primary endpoint [...] xtract (1650mg in 6 capsules) taken orally on a daily basis (QD)along for up to 7 months (including a 3-month run in period and 1 month for everywith Clomiphene citrate-intrauterine insemination (CC-IUI) cycle, up to 34 cycles if no pregnancy is achieved). Participant will stop green tea if she becomes pregnant. or matche [...] [...]
Study sitesdetails revised at 3 of 4 sites
2023-01-05
Study Status v6
Start date2022-12-01→2023-01
2022-11-09
Study Status v5
Start date2022-10-01→2022-12-01
2022-09-07
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start date2022-09-01→2022-10-01
Study sites0→4
Eligibility criteria+1,619 characters
[...] suspicion for intrauterine abnormality or tubal occlusion. Minimal, mild, or moderate endometriosis (per PI discretion). Evidence of ovarian function/reserve as assessed by day 3 (+ [...] medications which could interfere with the study (e.g., FSH, insulin sensitizers). Ability to have inseminations following hCG administratio [...] in any form during course of study participation in trial. - Exclusion Criteria: Participants with only intracavity uteri [...] e 2-6). Currently pregnant or successful pregnancies within 126 months of initiating participation. Clinical intrauterine miscarriages prior to initiating p [...] [...]
2022-08-15
Study Status v3
Primary completion date2025-05-31→2024-09-30
Completion date2025-06-15→2024-09-30
2022-08-10
Study Status v2
Start date2022-07-15→2022-09-01
2022-06-21
Study Status v1
Start date2022-06-01→2022-07-15
2022-05-03
Original filing
Yale University
487 trials monitored
See 35 trials at risk
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.
Trial Details
NCT Number NCT05364008
Lead Sponsor Yale University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Chicago, University of Illinois at Chicago, Johns Hopkins University
Conditions Leiomyoma, Uterine
Enrollment 33 participants
Start Date 2023-01-05
Primary Completion 2026-07-03 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-20