Research Programs

Research Programs

Gynecologic Oncology

Research in the section of gynecologic oncology has covered the gamut of gynecologic malignancies. We presently have phase 3 trials in ovarian, cervical and endometrial cancers, involving both national cooperative groups from the Gynecologic Oncology Group (GOG) as well as industry trials to assess the standard of care for these diseases. We are participating in phase 1 clinical trials nationally to evaluate cutting edge therapies for cervical and ovarian cancers, including antiangiogenic agents. Our clinical trials cover both primary therapy as well as recurrent disease, with the hope of expanding our knowledge as well as offering our patients unique treatments not offered elsewhere. Finally, our department is also investigating novel MUC1 vaccine agents in the attempt to prevent recurrence of ovarian cancer with some promising results.


Benign Gynecology

The Section of Benign Gynecology encompasses several specialty areas, including the Center for Menstrual Disorders, Fibroids and Hysteroscopic Services, the Center for Vulvar and Vaginal Health and the Chronic Pelvic Pain Program. Researchers in the Section of Benign Gynecology engage in a wide spectrum of clinical research to improve the care of patients with conditions such as abnormal uterine bleeding, pelvic pain and chronic vaginal conditions. Our research also focuses on predictors of surgical and postoperative complications and the prevention of surgical morbidity and mortality. The researchers in the Section of Benign Gynecology collaborate with experts in interventional radiology, pathology and other related specialties to advance our knowledge of these conditions. 

The Center for Menstrual Disorders, Fibroids and Hysteroscopic Services has internationally recognized gynecologic surgeons whose patient care and research is helping to change the field through collaborative research efforts in abnormal uterine bleeding, fibroids, endometriosis, adenomyosis and endometrial polyps. 

The Center for Vulvar and Vaginal Health is dedicated to research that has the goal of improving the quality of life our patients who experience recurrent or chronic discharge, discomfort or other related symptoms. The research focus of this group is on the vaginal microbiome and recurrent vaginitis and is aimed at finding ways to prevent and manage these conditions. 

The Chronic Pelvic Pain Program is dedicated to clinical and translational research focused on improving the lives of our patients. This research program emphasizes an interdisciplinary approach to the study of pelvic pain. Our clinician investigators collaborate with medical and surgical specialists from across the country and within Cleveland Clinic to increase our understanding and to optimize treatments for female pelvic pain disorders.  Ongoing areas of study and interest include:

  • A clinical trial that investigates the efficacy of an experimental electrical device for the treatment of chronic pelvic pain.  
  • A prospective clinical study evaluating the impact of novel surgical instruments for patients suffering from chronic pelvic pain
  • A study evaluating the use of patient-reported outcome questionnaires in assessing chronic pelvic pain improvement
  • Pelvic sensory discrimination mapping
  • Mucosal sensitivity in Vulvar Vestibulitis Syndrome

Urogynecology and Reconstructive Pelvic Surgery 

The Center for Urogynecology and Reconstructive Pelvic Surgery at Cleveland Clinic includes nationally and internationally recognized scientists and clinician-investigators performing basic, translational and clinical research dedicated to improving the understanding and treatment of pelvic floor disorders such as urinary incontinence, pelvic organ prolapse and fecal incontinence, in addition to vulvovaginal disorders, such as genitourinary syndrome of menopause and perineal disorders. Highlights of current research activities include:

  • Clinical trials evaluating the surgical and non-surgical management of stress urinary incontinence and pelvic organ prolapse.  The Center strives to study innovative devices and procedures that will advance the care for women who suffer from pelvic floor disorders.
  • Clinical studies evaluating minimally invasive treatments for pelvic floor disorders, including laparoscopic, robotic, and vaginal surgery with or without graft implantation.
  • Clinical studies to evaluate medium and long-term outcomes of surgery for pelvic floor disorders, including complex surgery for combined vaginal and rectal prolapse.
  • Studies to improve the classification and treatment of complications of transvaginal mesh procedures.
  • Cleveland Clinic has recruited patients and served as the data coordinating center for a national multi-center study evaluating two minimally invasive procedures that allow women undergoing surgery for uterovaginal prolapse to avoid hysterectomy.  Our center continues to study pelvic organ prolapse surgery for uterine preservation.
  • Cleveland Clinic has participated in and is currently participating in multiple 522 studies for surgical treatment of urinary incontinence and pelvic organ prolapse, the Pelvic Floor Disorders Registry, and the Pelvic Floor Disorders Network.
  • Clinical studies to evaluate postoperative opiate use after surgery for urinary incontinence and pelvic organ prolapse.
  • Clinical studies evaluating methods to decrease urinary tract infections and decrease catheter use after surgery for urinary incontinence.
  • Studies evaluating ways to measure and improve surgical competency and judgment among pelvic surgeons in training.
  • Studies evaluating use of CO2 fractional laser surgery for genitourinary syndrome of menopause and other vulvar and vaginal disorders.
  • Basic and translational research in pelvic floor disorders (www.lerner.ccf.org/bme/damaser).

Reproductive Endocrinology & Infertility

The Section of Reproductive Endocrinology and Infertility has an active and varied basic science and clinical research program. Residents at all levels of training are encouraged to participate in ongoing projects. The section also supports studies on other topics that residents may want to investigate. The following is a list of the areas of research our labs are currently pursuing:

  • Use of time-lapse imaging and morphokinetics in the IVF lab to improve clinical outcomes
  • Non-invasive techniques for assessing embryo vitality
  • Preimplantation genetic diagnosis to understand association between embryonic multinucleation and euploidy
  • Development of 3-D culture models for prolonged in vitro cultivation and maturation of mouse and  human preantral ovarian follicles
  • Study of extracellular matrix components and their role in folliculogenesis
  • Derivation and feeder-free culture of embryonic stem cell lines
  • Growth factor modulation of embryonic growth, blastocyst differentiation and apoptosis
  • Testicular/epididymal sperm and impact on embryo developmental dynamics
  • Development of methodology for single sperm cryopreservation
  • DNA fragmentation and embryo development
  • Characterization of endometrial secretions during the window of implantation
  • Optimizing ovarian tissue cryopreservation and transplantation
  • Role of microRNAs in endometriosis
  • ADAMTS and myoma extracellular matrix
  • Development of an anti-adhesion product for laparoscopic surgery

For more information on IVF Research please visit the Cleveland Clinic Beachwood Fertility Center.


Obstetrics and Maternal-Fetal Medicine

Researchers in the Section of Obstetrics and Maternal Fetal Medicine are committed to research that improves the health and wellbeing of women and children through a number of different areas, including: 

  • Genetic testing during pregnancy is a focus of our work. We are conducting a series of studies funded by the NIH to identify how to best integrate new prenatal genetic tests into patient care, including cell-free fetal DNA screening, one of the newest tests available to patients. Our goal is to find ways to help educate patients and doctors about these tests and then, ensure that patients can have effective discussions with their doctor about what test is right for them.
  • A focus of our research is cardiovascular complications of pregnancy, with an emphasis on preeclampsia and the identification of factors that cause this condition as a way to develop new approaches to early diagnosis and intervention. Current studies are looking at the effects of progesterone on activation of vascular endothelial cells by TNFα, sFlt-1 and sEng, and the role of heme oxygenases and carbon monoxide system. In addition, we are studying the potential impact of new insights into the natriuretic peptide system on hypertensive disease in pregnancy. We will also begin collaboration with Lerner Research Institute researchers investigating APO1 mutations responsible for the increased risk of preeclampsia in African American women. On the clinical side, we will soon be recruiting patients for a multi-center prospective randomized trial on treatment of chronic hypertension in pregnancy and we continue to participate in the PCOR study (Pregnancy and Cardiovascular Outcomes Registry), which looks at the relationship between certain complications during pregnancy and the development of cardiovascular disease later in life. 
  • Another focus is on how to optimize outcomes for women and children when an obstetric complication is identified. This includes studies looking at how to best plan for labor and delivery when a baby is diagnosed with meningomyelocele, one of the different types of neural tube defects that can be diagnosed early in pregnancy. We also have studies to help improve obstetric outcomes when a mother has diabetes or is diagnosed with this during her pregnancy. These studies will look at the effect of delayed cord clamping as a way to help babies thrive in the early days of life.  

Specialized Women's Health

The Center for Specialized Women’s Health encompasses holistic care of women, often with complex medical conditions, and provides cutting edge evidence based therapies. The research program emphasizes an interdisciplinary approach to the study of women’s health concerns. Collaboration between the multidisciplinary staff at the Center with a diverse group of clinicians from across Cleveland Clinic and Case Western university allows for novel approaches and the dissemination of the latest breakthroughs in women’s health research. Our staff have worked along with the Case Western School of Dentistry to examine periodontal issues in women taking bisphosphonate therapy and with Cleveland Clinic's Department of Radiology to assess compliance with osteoporosis screening. Ongoing areas of study include treatment of osteoporosis, gynecologic concerns after bone marrow transplant, resident education, cervical cancer screening, sexual dysfunction, pelvic organ prolapse and stress incontinence.


Global Women’s Health

The Section of Global Health is focused on how to best deliver high-quality, evidence-based healthcare to patients across the world, particularly in areas where women experience preventable diseases such as cervical cancer. Although preventable, cervical cancer is one of the leading causes of mortality for women in low and middle income countries. Researchers in the Section of Global Health focus on developing innovative and low-cost technologies adapted to detect, prevent, and treat precancerous lesions in resource-poor settings. Other projects conducted within the Section of Global Health include the development of an HPV self-sampling screening protocols to reach underserved women in Central American and China. 


Family Planning

The Section of Family Planning is deeply committed to research focused specifically on contraception and abortion that exerts a sustained and significant impact on women’s health,  reproductive advocacy and clinical practice. Our research team is dedicated to improving the overall quality of women’s health care by fostering innovative research and partnering with other Cleveland Clinic departments, institutes and organizations of excellence. This important multi-disciplinary collaboration allows for extraordinarily meaningful scientific input for the national and international reproductive health communities. Our projects currently center on investigating best practices in complex contraception, the use of LARC (Long-Acting Reversible Contraception) in the immediate post-partum period and post-abortive period, improving adolescent contraception, methods of abortion training and education, effectiveness of physician advocacy in protecting the reproductive rights of women, health care providers views on abortion, innovative policies to decrease the unintended pregnancy and neonatal mortality rates and new protocols for early pregnancy failure and post-abortion follow up procedures.

Research News

Research News

OB/Gyn and Women’s Health Perspectives

Cleveland Clinic's OB/Gyn and Women’s Health Institute publishes Perspectives to provide an overview of our clinical, translational, health services and basic science research toward the improvement of patients’ lives. In part because of the groundbreaking research initiatives currently being conducted at Cleveland Clinic, gynecology has been ranked 5th in the country by U.S. News & World Report.

View the most recent editions of OB/Gyn and Women’s Health Perspectives and the Year in Review:

Clinical Studies

Clinical Studies

CURRENTLY ENROLLING STUDIES

The following studies are either currently enrolling patients, or are on-going but are no longer enrolling patients.

Gynecological Cancers

View the complete list of Gynecological Cancer Clinical Trials


Pelvic Organ Prolapse

Title: Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
IRB: 14-260
Treatment: Pelvic Organ Prolapse
Status: Open
Principal Investigator: Marie Paraiso, MD
Research Line: 216.445.8090


Uterine Fibroids

Title: Prospective, Non-Interventional/Observational Registry of US Uterine Fibroids Patients (Capture-US)
IRB: 17-614 
Treatment: Uterine fibroids 
Status: Open 
Principal Investigator
: Linda Bradley, MD 
Research Line: 216.445.8090


Incontinence

Title: A Post-Market Evaluation of the Altis® Single Incision Sling System versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence (Altis 522 Study)
IRB: 15-1468
Treatment: Stress urinary incontinence (SUI) through cough stress test or urodynamics
Status: Open
Principal Investigator: Marie Paraiso, MD
Research Line: 216.445.8090


Prenatal Genetic Testing and Genetics in Women's Health

Preparing for emerging applications of noninvasive prenatal testing
Principal Investigator: Ruth Farrell, MD, MA

In this study, we are gathering information from patients and their partners to help us develop educational strategies to teach expectant parents and obstetricians about noninvasive prenatal genetic testing. To help design the educational materials, we are gathering input from pregnant women to learn about their experiences and perspectives if they had or heard about prenatal genetic testing. In addition, we are interested in the perspectives and experiences of partners of pregnant women. This study is funded by the NIH.

Who can participate in this study?

  • Any pregnant women who is receiving prenatal care at the Cleveland Clinic
  • The partner of a pregnant women who is receiving prenatal care at the Cleveland Clinic

For more information, please contact the Project Coordinator, Pat Agatisa, PhD, at agatisp@ccf.org or 216.444.0890.

Understanding the Drivers that Guide the Development of Prenatal Genetic Technologies
Principal Investigator: Ruth Farrell, MD, MA

In this study, we are investigating how a women decides if she is going to have prenatal genetic testing. This study is funded by the Templeton Foundation.

Who can participate in this study?

  • Any pregnant women who is receiving prenatal care at the Cleveland Clinic

For more information, please contact the Project Coordinator, Pat Agatisa, PhD, at agatisp@ccf.org or 216.444.0890.

Why Clinical Research

Why Clinical Research

Clinical research is medical research that involves people. Individuals volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose and understand human disease. There are strict rules for clinical research, which are monitored by the National Institutes of Health and the U.S. Food and Drug Administration.

Clinical research studies can be a means of developing new treatments and medications for diseases and conditions or a way to track information about medical conditions over time.

Ideas for clinical research often originate in the laboratory or patient-care settings. After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases. During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.

FAQ

FAQ

Why Participate?

Patients taking part in Ob/Gyn & Women’s Health Institute research studies at Cleveland Clinic are seen by a team of expert doctors, nurses, technicians, and support staff. Clinical research patients often are first to receive promising new treatments before they become available in the community.

Patients are helping others with the same disease, both today and in the future.


What should I consider when deciding to participate?

It is important that patients be well informed and feel confident and secure about participating. Before deciding to participate, you should talk with your own doctors, family members, and Ob/Gyn & Women’s Health Institute Research personnel.

Be sure you know the answers to the following questions before you make your decision:

  • What is the purpose of the study?
  • What is required of me?
  • What is my role in the study—am I a healthy volunteer or a patient volunteer?
  • Will the study directly benefit me?
  • Will the study benefit others?
  • Are there risks? If so, what are they and what are the chances that they will occur?
  • What discomforts are involved?
  • What is the total time involved?
  • Are there other inconveniences?
  • Have I discussed participation in the study with those who are important to me, such as family and friends?
  • Do I wish to participate in this study?

For more information about enrolling in the Ob/Gyn & Women’s Health Institute, please call 216.445-8090 (or toll-free 1.800.223.2273, ext. 58090).

Resources Contact

Contact

Women's Health and Ob/Gyn Institute Research and Innovations Leadership

Ruth Farrell, MD, MA
Vice Chairman of Clinical Research
farrelr@ccf.org
440.943.2500

Section Heads

Florida
G. Willy Davila, MD
davilag@ccf.org
954.659.5559

Reproductive Endocrinology
Nina Desai, PhD
desain@ccf.org
216.839.2907

Urogynecology
Marie Paraiso, MD
paraism@ccf.org
216.444.3428

Benign
Tosin Goje, MD
gojeo@ccf.org
440.312.2229

Obstetrics
Uma Perni, MD
perniu@ccf.org
440.312.2229

Gyn Oncology
Peter Rose, MD
rosep@ccf.org
216.444.1712

Global Health Research
Miriam Cremer, MD, MPH
cremerm@ccf.org
216.312.0618

Family Planning
Mitchell Reider, MD
reiderm@ccf.org
216.476.7000

For information  about our clinical research studies, please call 216.445.8090