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conFIRM
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INFORMATION FOR

conFIRM

FRIEND and PREGnant Consortia was formed in 2019 with investigators from Yale University, Johns Hopkins, University of Colorado, Northwestern University, University of North Carolina and the University of Illinois. The Consortia conducts and publishes high quality clinical studies.

Endometriosis and Fibroids in women are frequently reported problems of women in their reproductive years that can cause heavy periods, pelvic pain and difficulty achieving pregnancy. For reproductive aged women who are dealing with infertility issues due to endometriosis, and the general health in women with fibroids, the out of pocket cost can be astronomical. Treatment for reproductive system disorders such as endometriosis or fibroids may result in the loss of childbearing potential. Relatively few interventions and treatments for these disorders have been subjected to rigorous scientific evaluation.

The long-term objective of the Consortia is to improve the care of women with disorders affecting the reproductive system by conducting controlled clinical trials of therapeutic interventions. Funding for this research is provided by the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Yale Collaborative Center for Statistics in Science (C²S²), New Haven, Connecticut, coordinates the clinical trials for the Consortia. For more information about our studies go to Consortia Studies.

PREGnant

The goal is to conduct a prospective double-blind placebo-controlled trial that evaluates the likelihood of improving live birth rate through pre-IVF treatment with a GnRH antagonist in women with endometriosis.

Endometriosis has been estimated to affect up to 10–15% of reproductive aged women. Commonly, symptoms present during the reproductive years, being most widespread at 25–35 years of age. The association between endometriosis and infertility is well documented, however a definite cause-effect relationship is still controversial. The prevalence of endometriosis increases dramatically to as high as 25%– 50% in women with infertility and 30–50% of women with endometriosis have infertility.

Infertility is a common complication of endometriosis. While IVF successfully treats endometriosis-associated infertility, pregnancy rates are diminished compared to other etiologies of infertility. Our long- term objectives are to better identify and treat endometriosis related infertility. Our central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to placebo.

814 women with endometriosis between the ages of =18 and <38 years planning on undergoing IVF-ET for infertility management will be enrolled. This trial is funded by The Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD), National Institutes of Health (NIH).


pre-FRIEND

The goal is to assess the pharmacokinetics and hepatic safety of epigallocatechin gallate EGCG (Green Tea) in women with and without uterine fibroids done with a randomized, multi-center, pharmacokinetics and hepatic safety trial. The pharmacokinetics and hepatic safety of EGCG with clomiphene citrate and letrozole are unknown. The trial will be conducted in women with and without fibroids which will allow comparisons between these groups. The results of this study will be used to confirm hepatic safety for the larger multi-center FRIEND study.

Uterine leiomyomas (fibroids) affect 30-50% of reproductive-age women and are a significant cause of infertility. Intramural and submucosal fibroids reduce the likelihood of pregnancy (RR=0.3-0.7) compared to unaffected women. Surgical removal of fibroids can restore fertility, however recurrence rates are high and benefits are often temporary. Importantly, serious postoperative consequences such as adhesions can adversely affect a woman’s fertility and health in general. Hormonal therapies that induce medical menopause can be used to reduce fibroid size, but these therapies also prevent pregnancy. There is a critical need for effective, non-hormonal, non-surgical fertility treatment options for women with fibroids that may distort the uterine cavity. Our long-term goal is to develop novel non-hormonal treatments for uterine fibroids. Green tea leaves contain polyphenols and catechins, such as epigallocatechin gallate (EGCG). Studies from our group and others have shown that EGCG is the most abundant and active compound responsible for effects of green tea extracts. Notably, EGCG can be taken during pregnancy and there are no known teratogenic effects. EGCG polyphenols inhibit key pathways of tumor growth by modulating signaling pathways involved in cell proliferation, transformation, inflammation, apoptosis, metastasis and invasion.

36 women will be randomized to one of the following groups: EGCG daily alone, EGCG daily with clomiphene citrate and EGCG daily with letrozole. The randomization scheme will be stratified for age groups 18-29 and 30-40 and presence of uterine fibroids. This trial is funded by The Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), National Institute of Health (NIH).