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.


Female Pelvic Medicine and Reconstructive Surgery (FPMRS)

The Center for Female  Pelvic Medicine and Reconstructive Surgery (formerly 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. Highlights of current research activities include:


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. We will also support studies on other topics that they 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
  • Development of methodology for single sperm cryopreservation
  • Artificial blastocyst collapse to improve human embryo survival after cryopreservation
  • 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 human preantral ovarian follicles
  • Study of extracellular matrix components and their role in folliculogenesis
  • Derivation and feeder –free culture of embryonic stem cell lines
  • Co-culture models and identification of embryotrophic secretions
  • Growth factor modulation of embryonic growth, blastocyst differentiation and apoptosis
  • 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

Research activity in the section of maternal-fetal medicine primarily deals with the pathogenesis of preeclampsia. This includes the putative 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. Also, we are studying the potential impact of new insights into the natriuretic peptide system on hypertensive disease in pregnancy. On the clinical side, 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. Finally, we continue to assess the impact of new protocols for aneuploidy screening and patient preferences.


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.


General Gynecology and Pelvic Pain

The Chronic Pelvic Pain Program at the Cleveland Clinic is dedicated to clinical and translational research to improve the lives of our patients. Our 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 the 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

Global Women’s Health

Women’s Health Institute Global Health Research activities focus on cervical cancer prevention and treatment in multiple countries throughout the world.  This is a collaborative relationship between Cleveland Clinic’s Women’s Health Institute, Basic Health International www.basichealth.org (BHI) and Preventive Oncology International, Inc. www.poiinc.org  (POI), two non-profit medical research organizations founded by Cleveland Clinic physicians.  

BHI was founded in 2005 by Dr. Miriam Cremer with a mission to eradicate cervical cancer globally.  POI was founded by Dr. Jerome Belinson, former Chairman of Cleveland Clinic Department of Ob/Gyn, and has a mission to conduct research and provide education while working toward the prevention and early detection of gynecologic cancers. 

Dr. Cremer welcomes medical student, resident and fellow involvement in all projects. The best contact information is via email cremerm@ccf.org.

Dr. Cremer’s current activities with Basic Health International include:

  1. The Cervical Cancer Prevention in El Salvador (CAPE) is a joint effort between the Salvadoran Ministry of Health (MOH) and BHI to implement a 3-phase screening program of 30,000 women in the Paracentral region of El Salvador. This is the first time that HPV DNA screening has ever been used in a national implementation program.
  2. Self-sampling study. Women who did not come for provider-based screening in Phase 3 of CAPE will be approached in their homes and offered self-collection of a vaginal sample, which is an appealing alternative for many women. The aims of this project are multi-fold: to identify barriers to screening and attitudes about self-sampling, to determine if women who do not attend a clinic-based cervical cancer screening program will accept self-sampling at home, and to determine the rate of pre-cancer and cancer in this population.
  3. Dr. Cremer is a recipient of a $4M grant (over 5 years) from The National Institutes of Health (NIH). Dr. Cremer, along with several collaborators, is developing a CryoPen® Cryosurgical System adapted for low-and middle-income countries (LMIC) for the treatment of cervical pre-cancer. This innovative new device, which does not require cryogen gas, is part of the NIH initiative to support the development of cancer-related technologies suitable for use in these areas.
  4. A supplement to the NIH grant has been submitted to further study the question of what duration of cryotherapy most effectively causes the tissue necrosis necessary to prevent cervical pre-cancer from progressing to invasive cancer.
  5. Dr. Cremer is working on a R01 grant application to the NIH to fund a project tentatively titled: Development of an LMIC-adapted Thermocoagulation Prototype for the Treatment of Cervical Pre-cancer. This study proposes the rapid development and deployment of a novel point-of-care technology for the treatment of cervical pre-cancer. The proposed device uses thermocoagulation, also referred to as cold coagulation which uses a probe heated to 100-120º Celsius. No scientific evidence to date has investigated its efficacy and there are no standardized methods of timing or temperature for treatment. Since this rapid and inexpensive technology has the potential to address the need for more accessible treatment options, an academic industrial partnership has been formed to develop and test a thermocoagulation prototype.
  6. A team from BHI will be helping to do a cryotherapy training course in Rwanda November 2-6. We would be happy to take a resident or fellow but the interested party would be responsible for costs associated with travel.
  7. Other travel opportunities arise throughout the year mainly to work on projects in Latin America. I am happy to include residents and fellows particularly those who speak Spanish. There may be limited funds available for travel.

Dr. Belinson’s current activities with Preventive Oncology International, Inc. include:

  1. The Chinese Multi-Center Screening Trial (CHIMUST): The Prevention of Cervical Cancer Using Self-collection as the Primary Screen. 10,000 patient trial covering 5 sites from Inner Mongolia to Guangdong Province. The study will explore self-collection, three distinct assays, all integrated with the individual communities and local healthcare systems. – Planned initiation October-November.
  2. Ongoing development and phase I evaluation of a new Thermal Coagulator for outpatient management of pre-invasive cervical cancer. In Progres
  3. Development of a new solid media transport card for specimen transport with a special focus on self-collected specimens. Two studies completed (Oncology fellow project). Two papers submitted. Current work is now focusing on optimizing the card protocol for RNA detection
  4. Proposal completed and funding being explored for “Implementation of Community Based Cervical Cancer Screening Program in Northern Samar, Philippines”. This project hopefully can serve as a community based screening demonstration project for the Philippines. We plan to screen all the women ages 30-50 years in Northern Samar (est. 55-60,000). The plan is to screen and complete evaluation and management of the positives over a period of 2-3 months.
  5. Development and evaluation of a methylated version of SEQHPV (HR-HPV assay based on next gen sequencing). This project in collaboration with BGI Shenzhen is in its second year with more developmental work still ahead.

Over the past several years multiple students have done research with POI and traveled to the Dominican Republic, Mexico, Peru and China for those projects.

Usa Students In International Public Health

  • Suzanne Tisci, MPH, (University of Pittsburgh) – 2001
  • Robert Kim MD (Fellow, Cleveland Clinic – 2006
  • Pedro Escobar MD (Fellow, Cleveland Clinic) – 2005, 2006
  • Luis Rojas-Espaillat MD (Fellow, Cleveland Clinic) – 2006
  • Nabila Rasool MD, (Fellow, Cleveland Clinic) – 2008
  • Suzanne Belinson MPH, PhD (University of North Carolina) – 2008
  • Patrick Elliot MD, MPH (Case Western Reserve Medical School) - 2008
  • Lucybeth Nieves MD, MPH (Fellow, Cleveland Clinic) - 2010
  • David Starks MD, MPH, (Fellow, Cleveland Clinic) - 2011
  • Kim Levinson MD, MPH (Fellow, Cleveland Clinic) – 2011
  • Eunice Chyung MD (Case Western Reserve Medical School) – 2011
  • Carolina Abuelo MD (Fogerty Fellow, NIH) – 2012
  • Sara Goodrich MD, (Fellow, Cleveland Clinic) – 2012
  • Ali Usifoh MD, MPH (Cleveland Clinic Lerner College of Medicine) – 2013
  • Cynthia Arvizo MD (Resident, Cleveland Clinic) – 2014
  • Kathryn Maurer MD (Fellow Gyn Oncology Cleveland Clinic) – 2015

International Students

More than a dozen students have done projects leading toward Masters Degrees and PhDs in China.

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:

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: A prospective randomized trial comparing restorelle Y mesh vs. restorelle dual flat mesh for laparoscopic and robotic-assisted laparoscopic sacrocolpopexy
IRB: 14-354
Treatment: Pelvic Organ Prolapse
Status: Open
Principal Investigator: Cecile Unger, 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.


Women's Pelvic Pain

Title: A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy (VeLVET) in Women with Genitourinary Syndrome of Menopause (GSM)
IRB: 15-1570
Treatment: Postmenopausal women with vulvovaginal atrophy
Status: Open
Principal Investigator: Marie Paraiso, MD
Research Line: 216.445.8090

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