Category Archives: Research

New Evidence Supports Value of Preconception Weight-Loss for PCOS Patients

Until recently, specialists treating obese women with polycystic ovary syndrome (PCOS) have lacked research-based evidence to support the theory that weight-loss prior to fertility treatments may improve ovulation and, ultimately, live births. The topic had not been extensively studied, and most advice was from clinicians’ “common knowledge” that weight-loss prior to conception is beneficial. However, a recent study published in The Journal of Clinical Endocrinology & Metabolism1 now provides the clinical evidence to support that guidance. Richard S. Legro, MD, reproductive endocrinologist, Penn State Health Milton S. Hershey Medical Center, led the team that conducted a secondary analysis of two randomized trials to evaluate various approaches.1 They compared outcomes from the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial (n=187 women) of immediate treatment with clomiphene to outcomes from the treatment of Hyperandrogenism versus Insulin Resistance in Infertile PCOS Women (OWL PCOS) trial (n=142 women) of delayed treatment with clomiphene after preconception treatment with oral contraceptives, lifestyle modification or the combination of both.1 Continue reading

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OWL-PCOS Study Weight Loss Protocol

The OWL-PCOS study provided physicians with a detailed weight-loss strategy to share with their patients.1 Patients are instructed to take the following action:

  • Orlistat: (available OTC under the brand name Alli) to be taken as recommended + meal replacements contributing to a hypocaloric diet (~1200kcal/d) + lifestyle modification. To ensure adequate vitamin effects, take a vitamin supplement once a day, at least two hours before or after Orlistat. Institute Orlistat at a dose of 60 mg to be taken three times a day with meals. The dose may be skipped if the patient anticipates eating a high-fat meal to avoid the occurrence of unwelcome gastrointestinal side-effects.

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Groundbreaking Research Advances Women’s Health

Photo of a women's feet as she steps on a weight scale. A tape measure is positioned on the upper side of the scale.Research programs in maternal-fetal medicine, reproductive endocrinology, gynecologic oncology, female reproductive endocrinology and minimally-invasive gynecologic surgery at Penn State Health Milton S. Hershey Medical Center continue to advance the understanding of women’s health and garner placement in peer-reviewed clinical journals. This new knowledge translates from bench-to-bedside into improved diagnosis, treatment and prevention.

Reduction in the rate of Cesarean delivery following Consensus guidelines1

This before-after retrospective cohort study examined 200 consecutive nulliparous women managed prior to the Consensus for the Prevention of the Primary Cesarean Delivery guidelines were adopted, and then 200 similar patients after the guidelines were implemented. In one year, the Cesarean delivery rate among women delivering after induction or augmentation decreased from 35.5 percent to 24.5 percent; the overall rate decreased from 26.9 percent to 18.8 percent. Continue reading

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Novel Research Rotation Prepares Future Researchers and Clinicians

While many institutions have a general research requirement for residents, few have formally defined it. Beginning in 2016, however, all Penn State Health Milton S. Hershey Medical Center OBGYN residents are required to complete an officially sanctioned rotation on a self-developed research question. This rotation is overseen by Timothy Deimling, MD, director of resident research and assistant program director, fellowship in minimally invasive gynecology surgery, and Rebecca Phaëton, MD, assistant director of resident research. The research rotation helps each resident develop projects and identify mentors who are experts in their respective fields, and comprises two five-week blocks beginning in the resident’s second year. The ultimate goal is that each resident presents a publication-ready manuscript.

Photo of Timothy Deimling, MD, far left and, Rebecca Phaeton, MD, far right, meet with second-year residents to develop research questions.

Timothy Deimling, MD, far left and, Rebecca Phaeton, MD, far right, meet with second-year residents to develop research questions.

This was prompted by Dr. Deimling’s own experience as a resident; a research requirement frequently lacked dedicated time to develop that research. This reflects a common dilemma in medical education; clinical needs are prioritized at the expense of the more long-term research projects. As a Center of Excellence in the advancement of women’s health, Penn State Obstetrics and Gynecology has created this dedicated rotation to emphasize the importance of research, as well as the more widely recognized requirements of hands-on, clinical practice. The program is expected to expand, with measurement of future publication rates to mark its success. Continue reading

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Endometriosis Tissue Bank to Identify Key Biomarkers for the Disease

Timothy Deimling, M.D., Obstetrics and Gynecology, is in the final stages of obtaining institutional review board approval to launch a prospective database and tissue bank for endometriosis research. The primary purpose is to identify biomarkers for less invasive diagnosis, in addition to identifying targets for treatment of endometriosis. “Most women with pelvic pain and infertility obtain definitive diagnosis of endometriosis after a long history of problems; the delay in diagnosis is in large part due to the fact that it requires surgery,” notes Dr. Deimling. The tissue bank is being established according to guidelines set by the supporting World Endometriosis Research Foundation (WERF), and is planned to include multiple centers in the U.S. and internationally.

Pathology slide of endometriosis and picture of an endometriosis lesion

Pathology slide of endometriosis, as well as an intra-operative picture of an endometriosis legion.

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New Study Explores Pre-Treatment Lifestyle Modification for Obese Women with Unexplained Infertility

Obesity in women is associated with a negative impact on ovulation, delayed time to conception, increased pregnancy loss, and an increased risk of serious adverse maternal pregnancy and neonatal outcomes.1 A new randomized controlled trial recently began enrolling patients, aimed at evaluating the impact of two varying 16-week lifestyle modification interventions (see chart) on the frequency of healthy births (e.g., live birth at 37 or more weeks gestation with no major congenital anomaly, birth weight between 2500g to 4000g). To achieve a weight loss of approximately 7 percent of total body weight, the intensive intervention promotes increased physical activity combined with calorie restriction and a weight loss medication. The other standard intervention group promotes activity alone. Richard Legro, M.D., Penn State Hershey Obstetrics and Gynecology (lead study site), the lead investigator of this nationwide study explains, “Although the epidemiology of obesity and adverse fertility outcomes is well established, there is no evidence that losing weight or achieving fitness prior to pregnancy improves fertility. In fact, there are studies that show excessive weight loss or activity can harm the chances for pregnancy. We are doing this study to answer the question of what is safe and best for women seeking pregnancy.” Continue reading

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The First Baby Study: A Prospective, Longitudinal Investigation of the Relationship between Mode of First Delivery and Subsequent Fertility

First Baby Study Data

Data from retrospective study conducted 2000-2008 with reported deficits in childbearing subsequent to Cesarean delivery, prior to the First Baby Study. Cumulative percentage of women who had at least one further live birth over eight to nine years follow-up after first birth.1

While retrospective studies conducted in countries throughout the world have reported deficits in childbearing subsequent to Cesarean delivery (including a study conducted from 2000 to 2008,* see figure), the First Baby Study (FBS), conducted by researchers at Penn State Hershey Medical Center, is the first prospective interview study designed specifically to investigate the effect of Cesarean delivery on subsequent childbearing and understand why the post-Cesarean fertility deficit occurs. More than 3,000 women were interviewed during their third trimester, and again at one, six, twelve, eighteen, twenty-four, thirty and thirty-six months postpartum. These women delivered between 2009 and 2011 at seventy-six hospitals in Pennsylvania, and approximately one-third had a Cesarean delivery. The primary goal of the interviews was to measure factors related to subsequent childbearing – including marital and relationship issues, use of birth control, subsequent pregnancy intentions, unprotected intercourse over the three years of follow-up, and difficulty conceiving or carrying subsequent pregnancies. Continue reading

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A Resident-Based Multi-Center Research Study of Women in Active Labor

A group of investigators at Penn State Hershey Medical Center, including OB/GYN resident physicians as site investigators, have recently completed a multi-center clinical trial and published the results in the Journal of Maternal Fetal and Neonatal Medicine (March 2015). The objective of the study was to determine if the intrapartum use of a 5 percent glucose-containing intravenous solution decreases the chance of a Cesarean delivery for women presenting in active labor, under the theory that the glucose would provide adequate energy for the contracting uterus and prevent Cesarean delivery. Another objective was to bring together other Pennsylvania medical centers with obstetric residency training programs (Lehigh Valley Hospital, Reading Hospital, and St. Luke’s Hospital in Bethlehem) in this prospective and randomized study that analyzed 309 women. There was no significant difference in the Cesarean delivery rate for the glucose group (23/153 or 15 percent) versus the non-glucose group (18/156 or 11.5 percent). The authors concluded that the use of intravenous fluid containing 5 percent glucose does not lower the chance of Cesarean delivery for women admitted in active labor.

Jaimie Maines, M.D., former resident physician and soon-to-be faculty member in Penn State Hershey Women’s Health at the Medical Center, performed a key role in launching the study and co-authored the paper with Mary Anne Carrillo, M.D., a fourth-year resident in the department.

Jaimie Maines, M.D.

Jaimie Maines, M.D.

Mary Anne Carillo, M.D.

Mary Anne Carillo, M.D.

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When is Robotic Minimally Invasive Surgery the Approach of Choice?

RoboticSurgeryEquipmentA 42 year-old woman presents in the outpatient obstetrics and gynecology clinic with severe, uncontrolled pelvic pain, painful bowel movements, and constipation. The patient has a history of stage IV endometriosis and had conceived via in-vitro fertilization (IVF). The patient now desires definitive therapy; she has completed childbearing and she had unsuccessful medical management of her symptoms with oral contraceptives and a progestin IUD. Recent ultrasound revealed a large endometrioma in the right ovary. Colonoscopy results indicated deep endometriosis of the sigmoid colon.

Stephanie Estes, M.D., of Penn State Hershey Obstetrics and Gynecology says, “In complex cases like this, a minimally invasive surgical procedure using robotic technology in a single operation offers the best odds for success, both procedurally and with a good recovery. A gynecologic surgeon would begin with a hysterectomy, and then a colorectal surgeon would resect the affected portion of sigmoid colon en bloc, to complete the procedure.” Estes continues, “With the robotic surgical tools we use, there is definitely better dexterity and enhanced 3D visualization of tissue and organs, compared to an open abdominal approach. This minimally invasive approach is really key for complex cases with widespread pathology, to avoid injury to delicate surrounding tissues.” Continue reading

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Preclinical Findings Lay the Groundwork for Translational Research Program in Cervical Cancer

“Cervical cancers bear a viral antigen fingerprint that can serve as a target for radioimmunotherapy [RIT] that specifically destroys malignant tumor cells,” says Rebecca Phaëton, M.D., of Penn State Hershey Obstetrics and Gynecology. More than 95 percent of human cervical cancers express human papilloma virus (HPV) oncoproteins E6 and E7 (E=early transformation), which herald the beginning of malignant growth sequences. E6 and E7 are necessary for the malignant transformation and without their presence HPV would be incapable of being cancerogenic. In vitro and in vivo, proliferation of human cervical cancer cells reliably expressing E6 and E7 oncoproteins is significantly inhibited by C1P5, a murine monoclonal antibody (mAB) against E6.¹ Phaëton’s research, conducted with colleagues while a fellow at Albert Einstein College of Medicine, Montefiore, New York, demonstrated the ability of twenty μCi of the beta-emitting 188Rhenium-labeled C1P5 (i.p.) to selectively accumulate within HPV-16 positive human cervical cancer tumor cells in adult mice and to suppress tumor growth for up to twenty days after treatment.2,3 “Rhenium-labeled C1P5 accumulated in the cervical cancer cells of the mice, with limited to no accumulation in the liver, kidneys, and bone marrow. There was no sign of neutropenia in any of the subjects,” reports Phaëton. As shown in the diagram below, cross-linking C1P5, which targets intranuclear E6 with the beta-emitting 188Rhenium creates a chain reaction of cell death that may allow treatment to penetrate deep within the tumor. Continue reading

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