In this competing renewal, the Penn State RMN site brings significant strengths including 1) the PI providing leadership as Lead Investigator on the PPCOS II protocol, 2) serving as the top recruiter for two of the main RMN protocols in the last funding cycle, 3) supplying top quality data to the Data Coordinating Center, 4) providing key leadership on multiple committees, 5) authoring multiple high impact manuscripts, 6) facilitating collaborative ancillary studies in and out of the RMN, and 7) mentoring the next generation of clinical investigators. We propose to maintain our lead female and male investigators, as well as our experienced Nurse Study Coordinator/Research Assistant and add investigators with pediatric and adult endocrinology expertise as well as biostatistical expertise to assist us in bot designing new trials and writing up the results from our previous RMN studies. Additionally, we will partner with the University of Rochester in years 3-5, which will serve as a subsite for the studies we design for the RMN as well as provide investigator support and intellectual input for our concept protocol. Our site will continue to recruit in the surrounding rural areas around Penn State Hershey combined with a more urban/suburban population in Rochester. Our concept protocol builds on substantial preliminary data from a currently funded R01 trial based at Penn State (OWL PCOS) which allows for realistic projections of sample size, dropout rate and adverse event rates. Our RCT will test the hypothesis that a four month preconception weight loss arm in overweight/obese women with PCOS will improve live birth compared to a control intervention of continuous OCP in a total of 306 subjects. All women will then undergo four cycles of ovulation induction with an oral agent with timed intercourse. Additionally we will study women who conceive during pregnancy, and enroll infants in our Pregnancy Registry for 5 years. Participating male partners will be studied systematically throughout the trial. Our trial uniquely extends from preconception to infancy, utilizes a proven weight loss intervention, incorporates a unique multidisciplinary team of kinesiologist, nutritionist, and behavioral psychologist, and builds on the infrastructure of previous RMN studies.
In this competing renewal of our RMN site, we will continue our excellent track record of performance in infertility trials. We propose as a concept protocol, two arm clinical trial of a preconception intervention of weight loss vs. continuous OCP in overweight/obese women with PCOS designed to improve live birth rates. This study addresses an important public health issue on how to best treat infertility in overweight/obese women.
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