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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

• Baseline AMH ≥ 0.7 ng/ml.

• 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.

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

• In general, good health as assessed by PI, not taking any medications which could interfere with the study.

• Ability to have inseminations following hCG administration.

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

• 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.

Locations
United States
Connecticut
Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences
RECRUITING
New Haven
Illinois
University of Chicago, Department of Obstetrics and Gynecology
RECRUITING
Chicago
University of Illinois at Chicago College of Medicine
RECRUITING
Chicago
Maryland
Johns Hopkins, Division of Reproductive Science and Women's Health Research
RECRUITING
Baltimore
Contact Information
Primary
Ayman Al-Hendy, MD, PhD
aalhendy@BSD.Uchicago.edu
773-702-5954
Backup
Heping Zhang, PhD
heping.zhang@yale.edu
203-785-5185
Time Frame
Start Date: 2023-01-05
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 50
Treatments
Experimental: Green tea extract containing 45% epigallocatechin gallate (EGCG)
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
Placebo_comparator: Placebo
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
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: Johns Hopkins University, University of Chicago, University of Illinois at Chicago, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov