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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Green tea extract 1650 mg/day (45% EGCG) along with ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 4 cycles.
Placebo 1650 mg/day along with ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 4 cycles.
Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences
New Haven, Connecticut, United States
University of Illinois at Chicago College of Medicine
Chicago, Illinois, United States
University of Chicago, Department of Obstetrics and Gynecology
Chicago, Illinois, United States
Johns Hopkins, Division of Reproductive Science and Women's Health Research
Baltimore, Maryland, United States
Cumulative live birth rate.
The number of women achieving live birth.
Time frame: Up to 15 months
The conception rate
The number of women achieving conception
Time frame: Up to 6 months
The miscarriage rate
The number of women who have a miscarriage after conception.
Time frame: up to 8 months
The change of fibroid volume
The absolute change in fibroid volume (cm\^3) from baseline to completion of treatment.
Time frame: Up to 6 months
The change of fibroid symptom severity score
The absolute change in fibroid symptom severity summary scores from baseline to completion of treatment. It consists of an 8-item symptom severity scale. All items are scored on a 5-point Likert scale, ranging from "not at all" (1) to "a very great deal" (5). A high score means a worse outcome.
Time frame: Up to 6 months
The change of health-related quality-of-life questionnaire score
The absolute change in health-related quality-of-life questionnaire summary scores from baseline to completion of treatment. It consists 29 Health-Related Quality of Life items comprising 6 domains: Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from "none of the time" (1) to "all of the time" (5). A higher score means a worse outcome.
Time frame: Up to 6 months
Time to conception
The time from randomization to the first date of conception found
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Time frame: Up to 6 months