UC Health Reproductive Medicine Research (RMR)UC Health Reproductive Medicine Research (RMR) is the research center serving the Division of Reproductive Endocrinology and Infertility in Department of Obstetrics and Gynecology at the University of Cincinnati. Since the center’s inception in 1988, it has been a stand-alone research facility for conducting outpatient clinical trials specific to women’s health. Celebrating over 20 years of operation, UC Health Reproductive Medicine Research is committed to innovative scientific research for women. Major areas of research include: gynecology (contraception, menstrual cramps, endometriosis, vaginal infection), menopause (osteoporosis, libido, vaginal atrophy, hormone replacement therapies) and infertility. Currently under the direction of Michael A. Thomas, MD (Medical Director), and Rose A. Maxwell, PhD (Director of Clinical Trials), RMR provides the clinical infrastructure to support the research activities of the department’s faculty.
Our Mission Focus of our Research
Our Facility Funding for Our Research
Our Current Studies
What to Expect for Study Participants
Our Staff of Research Professionals Back to top
- contraceptive devices and methods
- menstrual cramps
- heavy menstrual bleeding
- vaginal infections
- female sexual dysfunction, libido
- menopause (hot flashes, vaginal dryness)
- Sexual satisfaction in couples undergoing infertility treatment or fertility preservation (nonprofit grant funded)
- Sexual satisfaction in couples following diagnosis and treatment of breast cancer (nonprofit grant funded)
- The impact of various treatment modalities on libido and sexual function in patients with urge incontinence (nonprofit grant funded)
- Efficacy and safety of human oocyte freezing in assisted reproduction (non-funded)
- Efficacy and safety of human ovarian tissue freezing in assisted reproduction (non-funded)
- Human sperm proteomics and glycomics – How does the sperm sialome contribute to fertility? (non-funded)
- Human uterine proteomics and glycomics – How does the endometrial sialome contribute to fertility? Assessment through uterine secretions obtained during sonohysterography (non-funded)
- Thin endometrium following clomiphene citrate for ovulation induction: Who is susceptible? (non-funded)
- The reproductive effects of the environmental toxin perfluorooctanoic acid in females undergoing in vitro fertilization (non-funded)
- Factors associated with pregnancy in Day 2 embryo transfers (non-funded)
Phase 1 StudiesPhase 1 studies are the first time an investigational drug is used in humans. Phase 1 studies are usually conducted in a small number of healthy volunteer subjects (typically between 20 and 80) and are closely monitored. The goals are to determine how the drug is absorbed and eliminated from the body, to determine a safe dose range for the drug and to gather information that will help researchers design a study for the next phase, Phase 2.
Phase 2 StudiesPhase 2 studies are the first examination of the effectiveness of an investigational drug for a particular condition. These studies are conducted in several hundred patients (200-300) who have the disease or condition. Phase 2 studies are typically well controlled and closely monitored to determine the preliminary effectiveness, short-term side effects and risks associated with the drug.
Phase 3 StudiesPhase 3 studies are performed if there is preliminary evidence of effectiveness for a particular condition (from Phase 2 studies). Phase 3 studies are needed to gather more information about a drug’s effectiveness, safety and appropriate dosage in different clinical settings. The goal is to evaluate the overall benefit-risk relationship (does the benefit outweigh the risks?) and to gather enough information for physicians and product labeling. Phase 3 studies are performed in a variety of clinical settings and in large numbers of patients (400-1,000s). Once the sponsor has gathered enough information from carefully designed studies and is able to show that the drug is safe and effective, the sponsor applies to the FDA for approval to market the drug.
Phase 4 StudiesPhase 4 studies are after-market studies. The FDA may ask the sponsor to gather additional information about the drug. Phase 4 studies may focus on gathering additional information about the drug’s risks and benefits, different doses or dosing schedules, different patient populations, different stages of the disease or effects of the use of the drug over longer periods of time.
Protecting youThrough all phases of drug development, the Code of Federal Regulations provides sponsors and investigators with guidelines for research and development. Sponsors and investigators must abide by these regulations when conducting clinical trials. These guidelines dictate various requirements of research including the informed consent process, safety monitoring, quality of the data and many more. This means that when you participate in a study all study procedures will be completely explained to you before you decide if you want to participate. All procedures that are performed for the study are at no cost to you and the results are closely monitored by the investigator. Your research records are confidential. You may be compensated for your time and travel. Back to top
Michael A. Thomas, MDDr. Thomas has been involved with the research center since its beginnings in 1988. He has participated in over 100 clinical trials, both NIH and industry sponsored, in his many years at the University of Cincinnati. Dr. Thomas has been the Medical Director of the research center for over 10 years.
Julie M. Sroga, MDDr. Sroga joined the University of Cincinnati faculty in 2012, after completing three years as a Reproductive Endocrinology & Infertility Fellow at the University of Cincinnati. Her research interests focus on polycystic ovarian syndrome, implantation, and oncofertility.
Krystene B. DiPaola, MDDr. DiPaola joined the University of Cincinnati faculty in 2010 after completing three years as a Reproductive Endocrinology & Infertility Fellow at the University of Cincinnati.
Rose A. Maxwell, PhDDr. Maxwell has served as Research Manager/Director of the research center since 2003 when she joined the Department of Obstetrics and Gynecology at the University of Cincinnati. Prior to that, Dr. Maxwell served as Statistician/Lab Supervisor for the Department of Psychiatry at UC. She has over 20 years of experience in research with 14 years in clinical trials. She directs all activities within the Division of Clinical Trials for the Department of OB/GYN including study project management, regulatory and study coordinating. She has several publications in the areas of OB/GYN, psychiatry/addictions and social psychology. She earned a PhD in Social Psychology from UC in 1996.
Deborah Boerschig, CNP, CCRCMs. Boerschig has over 37 years of experience in nursing with 20 years as a Nurse Practitioner and over 10 years of experience in clinical research. Ms. Boerschig earned Clinical Research Coordinator Certification in 2003. In her role as study coordinator, she has been involved in study screening/enrollment, performing all patient procedures within her scope of practice, completing Case Report Forms and maintaining regulatory files. She has assisted in protocol development for the Contraceptive Clinical Trials Network (CCTN, Principal Investigator: Michael Thomas, MD). She coordinates CCTN studies as well as a variety of industry-sponsored studies.
Tiffany RupertMs. Rupert has over 5 years of clinical research experience. Ms. Rupert is involved in study screening/enrollment, performing patient procedures, completing Case Report Forms and maintaining regulatory files. She coordinates studies with Ms. Boerschig for the CCTN as well as coordinating a variety of industry-sponsored studies.
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