The Reproductive Research Unit
Program Description
The Reproductive Research Unit (RRU) is a dedicated research facility, formally established in 1996 to centralize the rapidly growing clinical research initiatives in women's and reproductive health, and builds on Penn's long tradition of excellence in patient care and clinical research in this field. The mission of the RRU is to be a leader in the development of innovative reproductive health products and services that respond to the evolving needs of women and their partners; the Unit aims to excel as a clinical research partner to sponsors, collaborators and research volunteers alike.
RRU faculty, led by Kurt Barnhart, MD, MSCE as Director, have extensive experience in the successful conduct of both epidemiologic and multi-center clinical trials. Since its inception, the RRU has conducted over 45 Phase I-IV clinical trials across a broad range of indications including but not limited to family planning, diagnosis and management of infertility, miscarriage and ectopic pregnancy, post-menopausal syndromes, urogynecology, and vaginal infections. Major accomplishments of the Unit include recent publication of "A Comparison of Medical Management with Misoprostol and Surgical Management for Early Pregnancy Failure" in the New England Journal of Medicine, based on collaborative research concluding that misoprostol, administered vaginally, is an effective and safe alternative to surgery in the management of early pregnancy failure. The RRU also was centrally involved in a pivotal trial of Buffergel, a new nonhormonal method of contraception, to be featured soon in The Lancet in a special issue on contraception.
One of the main areas of interest of the RRU is the diagnosis and management of complications of early pregnancy, including miscarriage and ectopic pregnancy. A growing focus of the RRU's work is on the development of vaginally-applied microbicides that inhibit transmission of HIV as well as provide contraceptive efficacy. Microbicide trials include pioneering MRI studies of candidate product coverage of the vagina, surrogate markers of efficacy via post-coital testing, efficacy trials of actual use in fertile women, and colposcopic safety evaluations. Another core area of the RRU's current research efforts is in diagnosis and treatment of infertility. In particular, the Unit is facilitating the investigation of interactions between environmental factors and infertility by building a large-scale bank of blood and follicular fluid samples, accessible to multiple investigators with diverse projects in this area.
The RRU is conveniently located on the 8th floor of the Science Center at 3701 Market Street, adjacent to the clinical practice offices of Penn Fertility Care, with the Reproductive Surgical Facility just one floor below. This physical arrangement has promoted a mutually beneficial integration of research with clinical practice, with on-site access to physicians, a laboratory, and potential study participants. In addition to shared space, the RRU has its own dedicated research office space consisting of a mix of open-concept cubicles and private offices with a system of networked computers, a phlebotomy room, freezers, and secure clinical file and data storage.
The RRU is staffed by a fully on-site, highly trained and dedicated research team, comprised of four physicians, two advanced practice nurses, five clinical research coordinators, a regulatory specialist, a research assistant, and an administrative assistant. The unit's infrastructure allows it to independently perform all aspects of a project including protocol development, regulatory compliance, recruitment, screening, clinical examinations, specimen collection, data management, and preparation of publications. All studies undertaken by the RRU are continually monitored to ensure adherence to ethical standards of human subject research, and quality and integrity of data.
Program Members
- Kurt Barnhart, MD, MSCE (program leader)
- Samantha Butts, MD
- Clarisa Gracia, MD, MSCE
- Sarah Ratcliffe, PhD
- Mary Sammel, ScD
