Menstrual cycle regulation is a critical step in embryo implantation and successfully achieving pregnancy. Since a majority of cases of unexplained infertility may result from implantation failure, there is a need to assess the endometrium accurately for defects that could preclude implantation. Current tools for endometrial evaluation, however, are limited. Based on endometrial expression of cyclin E and p27, we have developed a patented endometrial function test (EFT®) which allows us to evaluate at a molecular level the menstrual cycle regulatory cyclins and to differentiate between normally and abnormally developing, endometrium.
Ultimately, we hope this test will prove useful to reproductive endocrinologists in evaluating menstrual cycle irregularities as well as implantation potential. In addition, given that cyclin E and p27 are regulated by estrogen and progesterone, this test may have a role in evaluating the effects of these hormones’ exogenous administration in infertility treatments as well as in other circumstances such as hormone replacement therapy of peri- and post-menopausal women and in clinical conditions that are known to alter or disrupt normal menstrual cycle function. Currently the EFT is used to evaluate patients with infertility and recurrent pregnancy loss. The full potential of these markers will need to be established with prospective, case-controlled multi-center trials that examine different groups of infertility patients to investigate the accuracy of the EFT in predicting pregnancy outcomes in natural cycles, IVF, and donor oocyte patients, work that is currently underway in our laboratory.