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Clinical Research Trials

The Department of Obstetrics and Gynecology has a very active clinical research program in every subspecialty. In 2007, we established the Women's Health Clinical Research Center under the direction of Dr. Kurt Barnhart. Many faculty members are trained in epidemiology and biostatistics or public health. There are numerous clinical trials available in reproductive health, contraception, infertility, gynecologic oncology, urogynecology, and obstetrics. The Division of Reproductive Endocrinology and Infertility has been a member of the Reproductive Medicine Network since it was established in 1990, and is one of eight centers in the country carrying out large, multi-center trials in the area of male and female infertility, and reproductive disorders. The Division of Gynecologic Oncology participates in the clinical trials sponsored by the Gynecologic Oncology Group (GOG) and in the phase I and II clinical trials in ovarian cancer offered through the Center for Early Detection and Cure of Ovarian Cancer.

Reproductive Health / Infertility

PANDORA (Periconception and Antepartum Nutrition, Developmental Outcomes and Reproductive Ability).  The purpose of this observational study is to test the association between preconception and mid gestation concentrations of micronutrients (Vitamin D, Folate, and Vitamin B12)  and endocrine disrupting chemicals  (Bisphenol A) with neonatal markers of growth and development.  Healthy women attempting pregnancy (with or without an infertility diagnosis) between the ages of 28 and 45 years are eligible for study.  It is hypothesized that micronutrient and/or environmental exposures during the periconception period and in utero impact markers of fetal growth and development and that such exposures at key windows may also predispose to metabolic diseases and ovarian dysfunction in adulthood.  Principal Investigator: Dr. Samantha Butts, MD, MSCE


Population Genetics of Polycysytic Ovarian Syndrome
This is a correlational study of androgen levels and gene identification in a sample of Polycystic Ovarian Syndrome (PCOS) patients and is being conducted at two sites: the University of Pennsylvania and the University of Iowa. The target enrollment for this study is 200 sets of women diagnosed with PCOS and both their biological parents, for a total of 600 subjects from both sites. A cohort of 100 women aged 18-50 with PCOS and their two parents will be recruited through the gynecological clinical practices, particularly Penn Fertility care. All subjects collect and submit a sputum sample for genetic analysis.   The major goal of this research project, the identification of genes contributing to PCOS, will provide basic understanding of the genotype-phenotype relationships that contribute to features of PCOS.  Knowledge of “PCOS genes” will assist physicians in practicing and assessing responses to interventions that promote fertility, improve insulin sensitivity, and treat other aspects of this disorder.  Principal Investigator:  Dr. Anuja Dokras-Jagasia
Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women

This open label, two site, clinical randomized trial will access a trend toward improvement in the live birth rate across 3 arms in 246 obese, infertile women ages 18-40, who have been diagnosed with polycystic ovarian syndrome.  Arm A:  an intervention to improve insulin sensitivity via lifestyle modification (weight loss and physical activity program); Arm B: an intervention to improve hperandrogenism via continuous oral contraceptive (OCP) use; and Arm C: an intervention that combines both lifestyle modification with continuous OCP use. The study will include 3 phases covering the continuum from preconception to birth.  Phase I (a pre-conception intervention x 4 months prior to ovulation induction), Arm A will complete intense lifestyle intervention (sibutramine + meal replacements + lifestyle modification); Arm B will be treated with continuous OCP and Arm C will receive both treatments.  Phase II will include up to 4 cycles of ovulation induction with clomiphene citrate.  Participants who conceive will be monitored for pregnancy complications in Phase III. Principal Investigator:  Christos Coutifaris

Serum Bank for Assessment of Markers for Ectopic Pregnancy
The purpose of this protocol is to develop a bank of serum specimens for a series of pilot studies and to determine the predictive ability of serum markers to distinguish among normal first trimester pregnancy, early miscarriage, and ectopic pregnancy. The study population is women experiencing vaginal bleeding and/or cramping in early pregnancy. Serum leftover from routine clinical tests is banked so that these markers can be retrospectively measured and correlated with clinical diagnoses. Principal Investigator: Dr. Kurt Barnhart

Stability and Epigenetic Structures in ART Children
This five year prospective study seeks to determine whether Assisted Reproductive Technology (ART) increases the possibility of deregulated expression of imprinted genes and/or destabilizes epigenetic chromosomal marking. It is hypothesized that in vitro manipulation procedures and/or intracytoplasmic sperm injection (ICSI) can destabilize the faithful propagation of epigenetic structures in the genomes of cells of the human embryo. With samples of cord blood, cord and placental tissue this study will look at and compare the regulation of such genes in 500 babies conceived with ART and 500 babies conceived without any fertility drugs and/or procedures. Principal Investigator: Dr. Christos Coutifaris

  • For more information about our clinical trials in reproductive health and infertility, please call 215-662-7727 or send an email to reproresearch@obgyn.upenn.edu

Oncofertility

Ovarian Tissue Freezing Prior to Chemotherapy or Radiation Therapy
Chemotherapy and radiation therapy for cancer can compromise the ability to become pregnant. The primary objective of this study is to establish a technology that will enable long-term preservation of ovarian function, including the production of viable oocytes, by cryopreservation of ovarian tissue prior to chemotherapy and/or radiation. Another aim of the study is to develop in vitro techniques that will allow maturation of oocytes from the cryopreserved ovarian tissue. Before receiving chemotherapy or radiation therapy, subjects will have one of their ovaries, or small pieces of both ovaries, removed by surgery. The tissues will be frozen by a special method in an effort to prevent the eggs from being damaged. The majority (80%) of the tissue will be stored for potential use in case that the patient is unable to achieve pregnancy in the future, while the remainder (20%) will be used for studying how the eggs can be grown in the laboratory. Female patients, aged 18-42, in need of cancer treatment likely to adversely affect ovarian function, may be eligible to participate. Ovarian tissue cryopreservation for adolescent girls ages 13-17 is available through a similar research protocol at the Children’s Hospital of Philadelphia under principal investigator Dr. Jill Ginsberg. Principal Investigator: Dr. Clarisa Gracia

Follicular and Luteal Dysfunction in Cancer Survivors (Daily Hormone Study)

 If you are between the ages of 20-35 or 43-50 with regular menstrual cycles and not using hormonal medications, we need you! Both women with a history of chemotherapy and women who have never had chemo are eligible. Give us a call if you think you might be interested. We would be happy to screen you for eligibility and answer your questions. 

This is a 1-2 visit study. At your visit, we will do a brief interview, take your height and weight, do a urine pregnancy test and send you home with 2 boxes of 5 ml tubes for daily urine collection and freezing. You will only collect 5mls (about a teaspoon) a day. That’s it! At the end of two menstrual cycles, we will arrange for pickup of the frozen kits or you may deliver them to our office. You will be compensated for the study visit and each completed collection cycle. Principal Investigator: Dr. Clarisa Gracia

Assessing Fertility Potential in Female Cancer Survivors (For Non-Cancer Patients) Healthy women ages 11-35 are invited to participate in a 5-year study comparing changes in ovarian function over time to the same measures in cancer survivors. Eligible women will be asked to complete a yearly questionnaire, brief physical examination, pelvic ultrasound, a blood test andto keep a menstrualdiary. Participants must have regular menstrual cycles (every 21-35 days), a uterus and both ovaries, body mass index (BMI) less than or equal to 30, and no medical condition associated with early ovarian failure. Participants must not have been pregnant or breastfeeding in the 3 months prior to participation, and must not be using or have used hormonal medication including contraceptives in the 3 months prior to study participation. Compensation is available.  Principal Investigator: Dr. Clarisa Gracia

Assessing Fertility Potential in Female Cancer Survivors (For Cancer Survivors)
Cancer survivors 15 to 35 years of age with a history of treatment with chemotherapy or radiation are eligible to participate in this study. Eligible women will be asked to come to the Reproductive Research Unit at Penn Fertility Care to complete a questionnaire, a brief physical examination, an ultrasound and a blood test yearly to assess changing ovarian function over time after cancer therapy. Participants will also keep a menstrual diary between annual visits. In addition, participants in this study will have the option of undergoing an additional, more sensitive test to assess their ovarian function. This test is called the clomiphene challenge test and involves taking clomiphene citrate for five days and having a repeat blood draw on the 10th day of the menstrual cycle. Principal Investigator: Dr. Clarisa Gracia

Ovarian Reserve After Cancer: Longitudinal Effects (ORACLE) (For Non-Cancer Patients)
Healthy women ages 11-35 are invited to participate in a 2-year study comparing changes in ovarian function over time to women undergoing treatment for cancer. Participants must have regular menstrual cycles (every 21-35 days), a uterus andat least oneovary, no medical condition associated with infertility, no treatment with chemotherapy or radiation therapy and must not have been treated with chemotherapy or radiation therapy and not have been pregnant or breastfeeding in the 3 months prior to participation. Compensation is available.  Principal Investigator: Dr. Clarisa Gracia

Ovarian Reserve After Cancer: Longitudinal Effects (ORACLE) (For Cancer Patients)
Patients about to begin treatment with chemotherapy or radiation therapy, who are between the ages of 11 to 35 years, may participate in a study measuring ovarian function over time. Eligible women will be asked to complete a questionnaire, a brief physical examination, an ultrasound and a blood test before, during and after cancer treatment. Visits will occur every three months for a total of seven visits over 18 months. Every attempt will be made to coordinate research visits with clinical appointments. Principal Investigator: Dr. Clarisa Gracia

Gynecology Oncology

UPCC:  16813:  A Phase 2, Open-Label Study Of Rucaparib In Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer.

The experimental drug being investigated in this study is called rucaparib.  Rucaparib is being developed by Clovis Oncology, Inc., a biopharmaceutical company based in the US and the United Kingdom.  Rucaparib belongs to class of anti-cancer agents known as PARP inhibitors.  PARP is a protein inside cells in the body that helps repair damage to DNA, which is the genetic material that carries the instructions for your body’s growth and development.  Cancer can result from changes in a person’s genetic material (sometimes called DNA mutations) and some of these changes can cause cancer cells to grow out of control.  Research has shown that PARP inhibitors stop the PARP protein from working, and that can sometimes cause cancer cells to stop growing.  If you complete the screening phase and meet all requirements, you will be enrolled into the study.  You will take rucaparib twice daily for treatment cycles of 28 days each.  During the first treatment cycle, you will have to return to the study center at about half way through the cycle and then again at the end of the cycle.  After the first cycle is completed, you will need to return to the study center approximately once every 4 weeks.  You can continue with additional treatment cycles for as long as the study doctor thinks it is in your best interest.  After you finish study treatment with rucaparib, you will need to complete an end of study treatment visit and then return to the clinic 28 days later for an end of study visit.

Principal Investigator:    Mark A. Morgan, M.D

 

UPCC: 24813:   A Phase 1, Open-Label  Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL. 

PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial lesions (HSIL) of the cervix and induces a measurable immune response. This study will evaluate the safety and tolerability of escalating doses of PEK fusion protein vaccine (PEK+GPI-0100) administered at one-week intervals by subcutaneous (sc) injections.  Expectation of the total duration of the study is 6 months. Individual patient participation is approximately 10 weeks inclusive of screening and follow-up. 

Principal Investigator:   Janos Tanyi, M.D., Ph.D. 

Recurrent Ovarian Cancer

UPCC: 19809: A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded with Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube cancer.

This is a three cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide.  Study duration is 24 months. Study Sponsor: Dr. George Coukos.  Principal Investigator: Dr. Janos Tanyi

UPCC 26810: A Phase-I Trial of Adoptive Transfer of Vaccine-Primed CD3/CD28 Costimulated Autologous T-Cells Combined with Vaccine Boost and Bevacizumab for Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer Previously Vaccinated with Autologous tumor Vaccine.

 This is a phase-I clinical trial to determine the feasibility and safety of cyclophosphamide/fludarabine lymphodepletion followed by adoptive transfer of vaccine-primed, ex vivo CD3/CD28-costimulated peripheral blood autologous T cells, followed by vaccination with OC-DC, an autologous dendritic cell (DC) vaccine loaded with autologous oxidized tumor cells, administered intradermally followed by Bevacizumab in patients with recurrent ovarian cancer, fallopian tube or primary peritoneal cancer who previously underwent induction vaccination with whole tumor vaccine (UPCC 19809; UPenn IRB# 810271;) or (UPCC 29810; Penn IRB # 812800).  Study Sponsor: Dr. George Coukos. Principal Investigator: Dr. Janos Tanyi

Platinum Resistant Ovarian Cancer

UPCC-06507:  A  phase I, open label, dose escalation, multiple dose study of the safety, tolerability,  and immune response  of crs-207 in adult subjects with selected  advanced solid tumors who have failed or who are not candidates for standard treatment. Principal Investigator: Dr. Dan Sterman, Co-Principal Investigator: Dr. George Coukos

  • For more information about our GOG clinical trials in gynecologic oncology, please call 215-614-0234 or email ybarrac@obgyn.upenn.edu

  • For more information about our ovarian cancer immunotherapy clinical trials in gynecologic oncology, please contact our Clinical Team 215-615-7447 or email OCRC.Trials@uphs.upenn.edu

Maternal Fetal Medicine

NICHD Nulliparous Outcomes Study:  Monitoring Mothers-to-be (nuMoM2b)
The goals of this study are to determine maternal characteristics that influence or predict Adverse Pregnancy Outcomes (APOs,) identify aspects of placental development that lead to APOs, and characterize genetic, growth, and developmental elements of the fetus associated with APOs.  First-time mothers who have a singleton pregnancy (not pregnant with twins), are less than 14 weeks pregnant, and plan to deliver within the Penn Health system are eligible to participate.  Eligible women will come to a site at University of Pennsylvania or Pennsylvania Hospital 3 times throughout their pregnancy to answer surveys, have blood drawn, and have ultrasound exams.  Additional samples may be collected at delivery.  Principal Investigator:  Samuel Parry, MD

  • For more information about our clinical trials in maternal fetal medicine, please call 215-662-7727 or send an email to reproresearch@obgyn.upenn.edu

Urogynecology

Refractory Overactive Bladder: Sacral Neuromudulation v. Botulinum Toxin Assessment (ROSETTA)

The purpose of this randomized, open label, active-control trial is to compare the effectiveness of an experimental treatment, botulinum toxin A (BOTOX) versus standard of care sacral neuromodulation (INTERSTIM) for the treatment of urge urinary incontinence (UUI). This study will look at women with refractory and severe UUI i.e. women who have failed conservative management and have at least 6 episodes of UUI on the bladder diary.  Effectiveness data will be collected at 3, 6, 12, and 24 months after the intervention. Principal Investigator: Lily A. Arya, MD 

Validation of Instruments for Pragmatic Clinical Trials for Overactive Bladder

The purpose of the study is to assess your urinary symptoms, their impact on your quality of life, and the effect of treating these symptoms.  We also want to measure your willingness to stay on medication (adherence).  This study will last for 3 months past the screening visit.  Visits include screening (physical exam and urine testing); baseline visit (bladder diary; questionnaires; medication); 2 week follow-up phone call; 8 week follow-up visit (in office: bladder diary; questionnaires) and 3 month follow-up visit (identical to 8 wk. visit). Principal Investigator: Lily A. Arya, MD

Functional Status in Older Women Undergoing Surgery for Pelvic Organ Prolapse

This prospective longitudinal observational study will assess the functional status of women over the age of 60 undergoing surgical treatment for pelvic organ prolapse. All women will complete questionnaires regarding functional status, co-morbidities, and frailty at a baseline visit. Surgery for pelvic organ prolapse will be performed by the treating surgeon. Women will then report for post-operative follow-up visits at 6 and 12 weeks following surgery. Questionnaires measuring functional status will be completed at these visits as well. Principle Investigator: Lily Arya, MD

Family Planning

Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel Using the BAT 24 Regimen Versus Daily and Pericoital Dosing

This study will assess the impact of different vaginal dosing regiments on the PK and PD of tenofovir 1% gel and the impact of these dosing regiments on immune cell activation (and possibly mucosal histology).  Specifically, this study will assess tissue after a single study-related sex act and after two weeks of twice weekly study-related sex for the following:

  • Tenofovir concentrations in blood plasma, aspirate, tissue, and cell pellet from cervicovaginal lavage
  • Tenofovir Diphosphate concentrations in peripheral blood monomuclear cells, endocervical cells, tissue, and cell pellet from cervicovaginal lavage
  • The effect of tenofovir on HIV-1 infection (and possibly HSV infection) in an explant challenge model
  • Anti-HIV and anti-HSV activity in cervicovaginal lavage
  • Immune cell activation (and possibly mucosal histology)

Principal Investigator:  Courtney A. Schreiber, MD, MPH

Efficacy of an Investigational Intrauterine System (IUS) as Compared with Mirena®This is a phase 3, randomized, open-label study of a levonorgestrel-releasing intrauterine system as compared with Mirena® in 18-45 year old women requesting long-term, reversible contraception. Women who present to the Penn Family Planning and Pregnancy Loss Center requesting long term contraception will be offered participation in this study. Participants will receive either the Mirena®, a currently approved IUS, or the LNG20, an investigational device with the same hormone (levonorgestrel) at the same dose (20mcg/day) as the Mirena®.  Subjects will be enrolled for up to 5 years to assess efficacy, safety, tolerability, bleeding patterns, and continuation of the intrauterine system. In addition, plasma levonorgestrel levels will be assessed at regular intervals in a sub-group of participants to consider an extension of the duration of the use of LNG20 past month 60 (year 5). Principal Investigator: Courtney A Schreiber, MD, MPH

A Pilot Study to Evaluate A Physician-Assisted Decision Tool to Improve Continued Contraceptive Use and Extend the Interval to the Next Pregnancy Compared with Routine Care
This cohort study will explore whether focused contraception counseling using a novel tool improves contraception adherence in the post-partum period. Subjects will be recruited from the population of adult women ≥ 32 weeks gestational age presenting for prenatal care at the Helen O. Dickens Center at the Hospital of the University of Pennsylvania. They will be randomly assigned to receive either contraceptive counseling using the decision tool or routine care. Subjects will complete a questionnaire surveying experiences and opinions on contraception and contraceptive counseling at a prenatal visit and by phone at three months postpartum. Principal Investigator: Courtney Schreiber, MD, MPH

Studies for Menopausal Symptoms  

Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study

This is a small clinical trial to assess if vilazodone (an SSRI) reduces the frequency and severity of menopausal hot flashes. Women aged 45-60 who have gone at least 60 days without a period in the last year and who experience bothersome hot flashes daily are invited to participate. Eligible participants will be randomized to 8 weeks of treatment with vilazodone or placebo. An additional aim is to identify improvement in menopause-related quality of life. Outcome assessments are the frequency and severity of hot flashes and clinical improvement. Approximately 30 women will be enrolled at the University of Pennsylvania. Principal Investigator: Dr. Ellen W. Freeman

  • For more information about studies for menopausal symptoms, please call Women's Health Research, Mudd Suite, 215-662-3329 or 1-800-662-4487

Women's Behavioral Wellness

Depression and Pregnancy Research Study
Are you pregnant and suffering from depression?  Are you looking for a non-medication based treatment to help with your symptoms?  The goal of this study is to investigate a new treatment for depression during pregnancy called Transcranial Magnetic Stimulation (TMS).  TMS is a non-invasive method used in the treatment of depressive symptoms.  TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more effectively with one another.  Effective neuron communication leads to lessening of depressive symptoms.  TMS requires daily (Monday through Friday) treatment for approximately 4 weeks.

Principal Investigator:  Dr. Deborah Kim

Clinical Research Coordinator: Lisa Lamprou

Telephone: 215-573-8880

Email: llamprou@upenn.edu  

Smoking and the Female Brain
Healthy women who smoke at least 1 pack of cigarettes a day are needed to participate in a paid brain imaging study.  While you do not have to be ready to quit smoking to participate in this study, information on how to quit will be provided.  The purpose of this study is to learn more about the effects of nicotine on brain chemicals and how they may differ between men and women.  PCWBW is seeking women and men 18-50 years old who are in good physical and smoke at least 1 pack of cigarettes per day.  

Principal Investigator: Dr. C. Neill Epperson

Clinical Research Coordinator: Claudia Schinstine

Telephone: 215-573-8878

Email: sclaud@upenn.edu  

Menopause & Memory Study

Have you ever walked into a room and couldn’t recall what you went there for?  Do you forget something if you don’t write it down?  Do you find yourself having to read the same page of a book over and over again?  These are common complaints reported by women as they progress through the menopause.  For some women, these changes in cognition can be very frustrating and affect their sense of well-being.  Our Center is studying whether a medication that is typically used to treat individuals with attention deficit disorder can improve memory, focus, and attention in menopausal women. Principal Investigator: Dr. C. Neill Epperson

Clinical Research Coordinator: Jeanette Bradley

Telephone: 215-573-8884

Email: jbradl@upenn.edu  

Estrogen, Serotonin and Memory in Menopause

The purpose of this study is to look at how estrogen affects memory, emotions, and brain activity in menopausal women.  The length of time you'll be on estrogen or placebo is approximately 10 weeks.  This is also a brain imaging study in which you will participate in 4 fMRI scans; 2 before beginning estrogen or placebo treatment and 2 after starting estrogen or placebo treatment.  PCWBW is looking for women who are peri- or post-menopausal, non-smokers, and not taking hormones, including birth control pills. Principal Investigator: Dr. C. Neill Epperson

Clinical Research Coordinator: Claudia Schinstine

Telephone: 215-573-8878

Email: sclaud@upenn.edu

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