{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T11:27:21Z","timestamp":1787311641534,"version":"build-2736575974"},"reference-count":54,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2023,1,9]],"date-time":"2023-01-09T00:00:00Z","timestamp":1673222400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","award":["R01 HD100365"],"award-info":[{"award-number":["R01 HD100365"]}]},{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","award":["R01 HD100367"],"award-info":[{"award-number":["R01 HD100367"]}]},{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","award":["R01 HD100369"],"award-info":[{"award-number":["R01 HD100369"]}]},{"name":"Johns Hopkins University","award":["R01 HD100365"],"award-info":[{"award-number":["R01 HD100365"]}]},{"name":"Johns Hopkins University","award":["R01 HD100367"],"award-info":[{"award-number":["R01 HD100367"]}]},{"name":"Johns Hopkins University","award":["R01 HD100369"],"award-info":[{"award-number":["R01 HD100369"]}]},{"name":"University of Chicago and University of Illinois Chicago","award":["R01 HD100365"],"award-info":[{"award-number":["R01 HD100365"]}]},{"name":"University of Chicago and University of Illinois Chicago","award":["R01 HD100367"],"award-info":[{"award-number":["R01 HD100367"]}]},{"name":"University of Chicago and University of Illinois Chicago","award":["R01 HD100369"],"award-info":[{"award-number":["R01 HD100369"]}]},{"name":"Yale University","award":["R01 HD100365"],"award-info":[{"award-number":["R01 HD100365"]}]},{"name":"Yale University","award":["R01 HD100367"],"award-info":[{"award-number":["R01 HD100367"]}]},{"name":"Yale University","award":["R01 HD100369"],"award-info":[{"award-number":["R01 HD100369"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>A similar abstract of the interim analysis was previously published in Fertility and Sterility. EPIGALLOCATECHIN GALLATE (EGCG) FOR TREATMENT OF UNEXPLAINED INFERTILITY ASSOCIATED WITH UTERINE FIBROIDS (PRE-FRIEND TRIAL): EARLY SAFETY ASSESSMENT. Uterine fibroids are the most common cause of unexplained infertility in reproductive-aged women. Epigallocatechin gallate (EGCG), a green tea catechin, has demonstrated its ability to shrink uterine fibroids in prior preclinical and clinical studies. Hence, we developed an NICHD Confirm-funded trial to evaluate the use of EGCG for treating women with fibroids and unexplained infertility (FRIEND trial). Prior to embarking on that trial, we here conducted the pre-FRIEND study (NCT 04177693) to evaluate the safety of EGCG in premenopausal women. Specifically, our aim was to assess any adverse effects of EGCG alone or in combination with an ovarian stimulator on serum liver function tests (LFTs) and folate level. In this randomized, open-label prospective cohort, participants were recruited from the FRIEND-collaborative clinical sites: Johns Hopkins University, University of Chicago, University of Illinois at Chicago, and Yale University. Thirty-nine women, ages \u226518 to \u226440 years, with\/without uterine fibroids, were enrolled and randomized to one of three treatment arms: 800 mg of EGCG daily alone, 800 mg of EGCG daily with clomiphene citrate 100 mg for 5 days, or 800 mg of EGCG daily with Letrozole 5 mg for 5 days. No subject demonstrated signs of drug induced liver injury and no subject showed serum folate level outside the normal range. Hence, our data suggests that a daily dose of 800 mg of EGCG alone or in combination with clomiphene citrate or letrozole (for 5 days) is well-tolerated and is not associated with liver toxicity or folate deficiency in reproductive-aged women.<\/jats:p>","DOI":"10.3390\/nu15020320","type":"journal-article","created":{"date-parts":[[2023,1,9]],"date-time":"2023-01-09T05:57:14Z","timestamp":1673243834000},"page":"320","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":37,"title":["Assessing the Hepatic Safety of Epigallocatechin Gallate (EGCG) in Reproductive-Aged Women"],"prefix":"10.3390","volume":"15","author":[{"given":"Hiba","family":"Siblini","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL 60637, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8778-4447","authenticated-orcid":false,"given":"Ayman","family":"Al-Hendy","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL 60637, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Segars","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of Illinois Chicago, Chicago, IL 60607, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugh S.","family":"Taylor","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale University, New Haven, CT 06520, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bhuchitra","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ainna","family":"Flaminia","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of Illinois Chicago, Chicago, IL 60607, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerie A.","family":"Flores","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale University, New Haven, CT 06520, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory M.","family":"Christman","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, FL 32610, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hao","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Yale University School of Public Health, New Haven, CT 06510, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5489-2372","authenticated-orcid":false,"given":"Jeremy J.","family":"Johnson","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, University of Illinois Chicago, Chicago, IL 60607, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heping","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Yale University School of Public Health, New Haven, CT 06510, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,1,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"ElKafas, H., Ali, M., and Al-Hendy, A. 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