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

Leiomyoma, Uterine Clinical Trial

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

Status Recruiting

Clinical Trial 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 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.

Clinical Trial Description

The objective of this study is to conduct a randomized double-blinded clinical trial to determine the effect of low caffeine green tea extract on fibroids and subsequent pregnancy in women seeking fertility treatment. The investigators hypothesize that EGCG in low caffeine green tea extract will reduce the fibroid size, improve the quality of endometrium, and increase the likelihood of pregnancy. To test this hypothesis, the investigators propose a randomized placebo-controlled clinical trial to evaluate live birth outcomes for women with unexplained infertility who have uterine fibroids. Participants will be randomized to either oral low caffeine green tea extract (1650mg/day) vs. placebo along ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 4 cycles.

Endpoints

Primary Endpoint:

• Our primary endpoint is cumulative live birth rate.

Secondary Endpoints:

• The conception rate.

• The miscarriage rate.

• The change of fibroid volume, symptom severity score, and health-related quality-of-life score, from baseline to completion of treatment, and endometrial receptivity biomarkers.

• Time to pregnancy

This will be a randomized, multi-center, prospective, and double-blind clinical trial of low caffeine green tea extract versus placebo. Fifty (50) participants will be randomized via computer-generated randomization schedule to receive either:

1. low caffeine green tea extract (1650mg in 6 capsules) taken orally on a daily basis 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.

or

2. matched (smell, taste, color, texture) placebo capsules taken orally on a daily basis along with CC-IUI cycle, up to 4 cycles if no pregnancy is achieved. Participant will stop placebo if she becomes pregnant.

The randomization scheme will be on a 3:1 basis in favor of green tea extract, thus 37 participants will be assigned to the first arm (green tea extract) and 13 participants to the second arm (placebo).

Clomiphene citrate will be taken for 5 days on Day 3 +/- 2 days of the participant's cycle. ;

Related Conditions & MeSH terms

• Infertility
• Leiomyoma
• Leiomyoma, Uterine

• NCT number: NCT05364008
• Study type: Interventional
• Source: Yale University
• Contact: Ayman Al-Hendy, MD, PhD
• Phone: 773-702-5954
• Email: aalhendy@BSD.Uchicago.edu
• Status: Recruiting
• Phase: Phase 3
• Start date: January 5, 2023
• Completion date: December 30, 2025