1. To determine whether there is a specific VM profile in women diagnosed with unexplained infertility when compared to others.
2. To determine whether there is an association between ovulation induction (OI) cycle medication (med) protocol & the vaginal microbiome (VM) in women undergoing assisted reproduction: we will conduct a search for changes in the VM, as the cycle progresses, in low circulating serum estrogen (Estradiol (E2)) states such as OI with (w/) Letrozole or clomiphene citrate (CC) when compared to natural cycle or injectable gonadotropin OI.
3. To determine whether there is an association between circulating serum anti-muellerian hormone (AMH) levels & the VM profile: AMH is a marker of ovarian reserve/egg number & thus serves as a surrogate for predicting E2 and egg production in a cycle. Using this information, we will attempt to create a predictive model for success in such cycles including the VM profile.
4. To identify any changes in the VM amongst patients (pts) of different demographic profiles (body mass index (BMI), ethnicity/race, medical comorbidity, etc) but undergoing the same OI protocol: This will help to identify potential subgroups of pts for whom predictive modeling & diagnostic optimization in assisted reproductive cycles can be targeted.
5. To determine feasibility of testing for viral microbiomes in the vagina & endometrium of pts undergoing OI: We seek to partner w/ Ubiome to: 1. determine if common mucosal viruses which are known to shed into the vaginal tract can be identified using this non-invasive technology & 2. determine if hormonal shifts w/in OI cycles affect vaginal & cervical viral microbiome in pts.
Why This Project?
This project could extend the applicability for and utilization of microbiome testing. Specifically, this grant opportunity by Ubiome offers a potential to conduct a sentinel prospective cohort study in a high stakes area that has the potential to present broad reaching implications across a majority of the general population (reproductive aged men & women). Identification of key microbiota which will be ‘unmasked’ during this project, will then serve as building blocks for future diagnostic tests and therapeutic targets for individual patients with a host of reproductive disorders beyond infertility.
In the long term, we envision that the results of this study will serve as a framework for a key diagnostic assessment tool which will be routinely offered to patients planning conception or diagnosed with pregnancy. It is clear that the vaginal microbiome of each person is unique and therefore it is critical that we identify ways to aid in personalization of key medical services; paramount of which include reproduction.
About the Researcher
Dr. Duke attended the City College of New York/City University of New York and earned a Bachelor of Science degree in Biochemistry. Following college, she attended the University of Rochester School of Medicine and Dentistry where she completed the highly rigorous and selective NIH funded Medical Scientist Training Program to earn her Doctor of Medicine (M.D.) and Doctor of Philosophy (Ph.D.) degrees. Dr. Duke holds a Ph.D. in Microbiology and Immunology. Following Medical School, Dr. Duke completed her Medical Residency training in Gynecology and Obstetrics at the Johns Hopkins Hospital in Baltimore, Maryland and is a Diplomate of the American Board of Obstetrics and Gynecology. At present, Dr. Duke is on Faculty at the Yale University School of Medicine where she is Clinical Instructor in the Department of Obstetrics, Gynecology and Reproductive Sciences and Clinical Fellow in the Division of Reproductive Endocrinology and Infertility.
As a young physician scientist, Dr. Duke is a very effective communicator with a dynamic personality and outstanding people skills. She consistently works well with teams across different specialties and disciplines. Dr. Duke has received awards for “Excellence in Teaching”, has already published over 15 papers in her short career including a first author paper that was selected as a “recommended” publication by the Faculty of 1000 Medicine and currently has four clinical research papers under peer review & pending publication. This Grant will help to launch a pilot study that will bridge Dr. Duke’s clinical research goal of demonstrating a personalized link between the microbiome of the reproductive tract and reproductive outcomes in individual patients.