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.
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).