Research  :  Gynecological Research

BMI: CHANGE IN BMI AND CONTRACEPTION STUDY
PI: Jeffrey Peipert, MD • RA: Jennifer Wade
As a retrospective sub-study of the Contraceptive CHOICE Project, our goal is to measure the change in body weight and body mass index between baseline and 12 months in women who use the ENG implant, LNG-IUC, or depot medroxyprogesterone acetate for at least 11 months and to compare these measures to users of the copper IUC. We plan to enroll 100 participants in each group.

BACTERIAL-HOST INTERACTIONS IN VAGINAL FLUIDS
PI: Amanda Lewis, PhD • Co-PI’s: Jenifer Allsworth, PhD, Tessa Madden, MD, MPH
We have shown that sialidase activity can have a profound impact on the physical properties of proteins involved in mucosal immunity that are modified with sialic acid residues. Using clinical samples from women with or without BV, we aim to further characterize how sialidases may be involved in the initiation and complications of this infection using molecular, tissue culture, and animal models. Approximately 800 vaginal swabs will be collected through the VAST study over a 3 year period.

THE CONTRACEPTIVE CHOICE PROJECT
PI: Jeffrey Peipert, MD, PhD • Project Director: Gina Secura, PhD, MPH - Sponsored by an anonymous foundation
The study aim is to reduce the number of unintended pregnancies in the St. Louis area by providing no cost contraception of a woman’s choice for three years, including STD and HIV testing and STD treatment. Recruitment occurs at the Division of Clinical Research, as well as multiple family planning clinics in the St. Louis region. A total of 10,000 women will be enrolled over a four-year period with follow-up for three-years after enrollment.

DEVELOPMENT OF A CONTRACEPTIVE DECISION MAKING TOOL
PI: Tessa Madden, MD, MPH • Project Director: Gina Secura, PhD, MPH - Sponsored by a Society of Family Planning (SFP) Grant
The study will conduct the formative research necessary to develop a computerized decision-making tool that incorporates the social and cultural factors that influence women’s contraceptive decisions; and therefore increase satisfaction, knowledge, and decision certainty with the contraceptive decision-making process. Through focus groups, surveys and initial assessments among women and clinicians, a web-based interactive computerized tool will be developed and pilot tested among participants of the Contraceptive CHOICE Project.

DXA: WEIGHT CHANGE AND CONTRACEPTION STUDY
PI: Jeffrey Peipert, MD, PhD • RA: Danielle Grunloh
As a prospective sub-study of the Contraceptive CHOICE Project, our goal is to measure the change in body weight, body mass index, and body composition measured by dual-energy x-ray (DXA) technology between baseline and 12 months in women using the ENG implant, LNG-IUC, or depot medroxyprogesterone acetate and to compare these measures to users of the copper IUC. We will also examine whether appetite and physical activity change during this time period. Enrollment began in December 2010; 115 participants will be enrolled in each group. In addition, among the first 40 participants, we will compare body composition results of the DXA scan to results using a bioelectric impedance scale.

FACT (FERTILITY AFTER CONTRACEPTION)
PI: Amy Stoddard, MD • Co-PI:Jeffrey Peipert, MD, PhD • CRA: Hanna Xu
The FACT Study will assess time to pregnancy (fertility) after IUD removal, and compare this group to women discontinuing other contraceptive methods . Eligible participants will be between 18 and 35 years old and will have discontinued their contraceptive method within the past 60 days. Following enrollment, women will be followed-up with phone interviews at 6,12,18 and 24 months after method discontinuation.

A PHASE 3, RANDOMIZED, MULTI-CENTER, OPEN-LABEL STUDY OF A LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM AND MIRENA® FOR LONG-TERM REVERSIBLE CONTRACEPTION
PI: David Eisenberg, MD, MPH • RA: Kristen Powers Sponsored by Medicine 360
A Phase III, multi-center, randomized study aimed at evaluating whether the safety and effectiveness of LNG 20 intrauterine contraceptive system compared to the Mirena®. A total of 150 women will be recruited at the Division of Clinical Research.

MISTIC: MIRENA INTRAUTERINE SYSTEM TIMING OF INSERTION CONTROLLED TRIAL
PI: Lorie Harper, MD • Co-PI: David Eisenberg, MD, MPH
This substudy of the Contraceptive CHOICE Project is a randomized control trial with the aim of determining the timing of Mirena® insertion that results in the greater proportion of women with a Mirena® in place at 6 months post-partum. Women requesting the Mirena® for post-partum contraception will be enrolled at CHOICE sites at 36 weeks gestation or greater and will be randomized at the time of vaginal delivery to receive the Mirena® immediately post-placenta or at 4-8 weeks post-partum. Approximately 200 women will be randomized.

mtDNA ON FERTILITY
PI: Kelle Molle, MD
This is a sub-study of the Women and Infant’s Health Specimen Consortium study. The purpose of this study is to identify heteroplasmic mitochondria (mt) DNA mutations at the level of a single oocyte that can lead to decreased IVF efficiency and fertility.

NK CELLS AND IVF OUTCOME
PI: Joan Riley, PhD
This is a sub-study of the Women and Infant’s Health Specimen Consortium Study aimed to determine if the percentage of NK (natural killer) cells, their cell surface phenotype, or their cytokine production profile in follicular fluid can be used to predict pregnancy outcome. Specimens will be collected through the Women and Infant’s Health Specimen Consortium study from approximately 50 women.

OVARIAN RESERVE AND JUVENILE/ADULT RHEUMATOID ARTHRITIS & SPONDYLOARTHRITIS
PI: Amber R. Cooper, MD • CRNC: Mary Koenig, RN - Sample analysis supported by Beckman Coulter, Inc.
This is a prospective study aimed at evaluating ovarian reserve in females 4-50 years of age with the diagnosis of RA, JRA/JIA, or SPA (spondyloarthritis). The purpose is to evaluate the effects of disease severity and biologic/cytotoxic therapies on ovarian function. Recruitment of patients is at SLCH and the Rheumatology Clinic at the Center for Advanced Medicine and will continue until 300 patients are enrolled.

REPRODUCTIVE OUTCOMES IN OBESE WOMEN WITH INFERTILITY
PI: Emily Jungheim, MD
A prospective cohort study of obese versus non-obese women undergoing in-vitro fertilization with the objective to study potential contributions of leptin, and adiponectin to poor reproductive outcomes among obese women. Recruitment will occur in the Department of Reproductive Endocrinology and Infertility. Approximately 450 IVF cycles and seven patients will be recruited from each group through WIHSC.

THE VARIANT HOOK EFFECT IN OVER-THE-COUNTER hCG DEVICES
PI: Ann Gronowski, PhD • CRC: Christine Kramer
The objective of this study is to investigate whether very high concentrations of one variant form of hCG (hCG beta core fragment) would produce falsely negative hCG results in five commonly used qualitative OTC hCG devices and to also demonstrate the temporal nature of this effect in early pregnancy.

THE VAST STUDY
PI: Jenifer Allsworth, PhD • CRNC: Linda Odibo, RN, BSc, MN • RA: Molly Meyer
A prospective cohort study nested within the Contraceptive CHOICE Project that seeks to evaluate the role of genomic variation in Human Leukocyte Antigens in susceptibility to bacterial sexually transmitted infections (Chlamydia trachomatis and Neisseria gonorrhoeae). A total of 1,000 women between the ages of 18 and 45 years will be recruited.

VITAMIN D AND VAGINAL FLORA
PI: Jenifer Allsworth, PhD • Danae Larson, RN, BSN
A substudy of the Vitamin D Antenatal Asthma Reduction Trial that will evaluate the impact of Vitamin D supplementation during pregnancy on vaginal flora. Up to 150 women will be recruited.

WIHSC: WOMEN AND INFANT'S HEALTH SPECIMEN CONSORTIUM
PI: Ann Gronowski, PhD; Kelle Moley, MD; Jenifer Allsworth, PhD; Marwan Shinawi, MD • CRC: Christine Kramer • RAs: Lyndsay Roy, Kim Townsend, Bridget Conlon, Michele Landeau -  Sponsored by a Children's Discovery Institute Grant
The study aim is to create a structure to facilitate the collection of patient specimens for women and infant's health research. The bank will provide specimen collection, specimen storage and processing, as well as the maintenance of a comprehensive database of outcomes data for five hypothesis driven projects. This process will be completed by working together with the LTP (Laboratory Translational Pathology). Recruitment will occur at Washington University Reproductive Endocrinology and Infertility Center,the Center for Advanced Medicine, Barnes Jewish Women’s Health Clinic and Labor and Delivery. Approximately 2000 women and 350 infants will be enrolled.