Phase
Condition
Infertility
Uterine Fibroids
Sarcoma (Pediatric)
Treatment
Green Tea Extract
Placebo
Clinical Study ID
Ages 18-40 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 threedimensions. Participants with multiple fibroids including FIGO type 0 and type 1will 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, desirousof conceiving, regularly ovulating (defined as 9 or more menses per year), atinitiation of participation. Women < 35 years of age must have at least 12 months ofinfertility 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 precedingenrollment into the study. An uncomplicated intrauterine non-IVF pregnancy anduncomplicated delivery and postpartum course resulting in live birth within the lastthree years will also serve as sufficient evidence of a patent tube and normaluterine cavity as long as the participant did not have, during the pregnancy orsubsequently, risk factors for Asherman's syndrome or tubal disease or otherdisorder leading to an increased suspicion for intrauterine abnormality or tubalocclusion.
Evidence of ovarian function/reserve as assessed by day 3 (+/-2 days) FSH ≤12 IU/Lwithin one year prior to study initiation.
In general, good health as assessed by PI, not taking any medications which couldinterfere with the study.
Ability to have inseminations following hCG administration.
If applicable, the study participant will inform their partner of trialparticipation.
Male partner with total motile sperm in the ejaculate of at least 5 millionsperm/ml, within one year of study initiation.
Participant agreement to abstain from use of green tea products in any form duringcourse of study participation in trial.
Exclusion
Exclusion Criteria:
Participants with only intracavity uterine fibroid (FIGO Type 0 or Type 1) when notin combination with other types of fibroids (FIGO type 2-6).
Currently pregnant.
Clinical intrauterine miscarriages prior to initiating participation: participantsmust wait 3 months. No exclusion for biochemical pregnancies.
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 greentea require a 2-week wash-out.
Undiagnosed abnormal uterine bleeding.
Suspicious ovarian mass.
Participants on depo-progestins, or hormonal implants (including Implanon). Atwo-month washout period will be required prior to screening for participants onthese agents. Longer washouts may be necessary for certain depot contraceptive formsor implants, especially when the implants are still in place.
Known 21-hydroxylase deficiency or other enzyme defects causing congenital adrenalhyperplasia.
Uncontrolled diabetes with HbA1c > 6.5%
Known significant anemia (Hemoglobin <8 g/dL).
History of deep venous thrombosis, pulmonary embolus, or cerebrovascular event.
Known heart disease (New York Heart Association Class II or higher).
Known Liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5mg/dL).
Known Renal disease (defined as BUN >30 mg/dL or serum creatinine > 1.4 mg/dL).
History of, or suspected cervical carcinoma, endometrial carcinoma or breastcarcinoma.
History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6drinks at one time).
Known Cushing's disease.
Known or suspected adrenal or ovarian androgen secreting tumors.
Allergy or contraindication to the treatment medications: EGCG, clomiphene citrate (CC) or hCG.
Couples with previous sterilization procedures (e.g., vasectomy, tubal ligation)which have been reversed.
Participants with untreated poorly controlled hypertension defined as a systolicblood pressure ≥ 160 mm Hg or a diastolic ≥ 100 mm Hg obtained on two measuresobtained at least 60 minutes apart.
Participants who have undergone a bariatric surgery procedure in the recent past (< 12 months) and are in a period of acute weight loss or have been advised againstpregnancy by their bariatric surgeon.
Stage 3 and 4 endometriosis and endometriomas > 3cm (as per PI discretion) .
Known polycystic ovarian syndrome as evidenced by anovulation or oligoovulationhirsutism and/or elevated testosterone levels, and ovarian morphology on ultrasoundexamination.
Medical conditions that are contraindications to pregnancy.
Study Design
Study Description
Connect with a study center
Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences
New Haven, Connecticut 06520
United StatesActive - Recruiting
University of Chicago, Department of Obstetrics and Gynecology
Chicago, Illinois 60637
United StatesActive - Recruiting
University of Illinois at Chicago College of Medicine
Chicago, Illinois 60612
United StatesActive - Recruiting
Johns Hopkins, Division of Reproductive Science and Women's Health Research
Baltimore, Maryland 21205
United StatesActive - Recruiting
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