Newswise — In the United States, epilepsy affects nearly one million women of childbearing potential and whether there is increased infertility in women with epilepsy is presently unknown. People with epilepsy have been reported to have fewer children, however, the specific factors contributing to this lower birth rate are unknown. To try and get some answers, doctors at the North Shore-LIJ Health System’s Comprehensive Epilepsy Care Institute have begun enrolling volunteers to participate in a research study that also involves New York University and Harvard University.
The study will examine the patterns of fertility among women with epilepsy, compared to an age matched group of women without epilepsy. The research is being funded by the Milken Family Foundation.
“While it has been reported that fertility is decreased in women with epilepsy, little is known as to why this happens,” said Cynthia L. Harden, MD principal investigator of the study at North Shore-LIJ and chief of North Shore-LIJ’s Comprehensive Epilepsy Care Institute, part of the Cushing Neuroscience Institutes. “Another issue is that during the course of pregnancy for those women with epilepsy who do become pregnant, seizure patterns may vary. Therefore in the study we will also compare seizure frequency during pre-conception to seizure frequency during pregnancy.”
Participant Eligibility: To be eligible, volunteers must be females between the ages of 18-40 planning to get pregnant and not using any form of birth control. Participants must either have a diagnosis of epilepsy and for those without epilepsy, must be in general good health. Locally, the research study will be conducted at North Shore-LIJ’s Comprehensive Epilepsy Care Institute, based at Long Island Jewish Medical Center in New Hyde Park, NY. The study will last the entire duration of the pregnancy, and involves interviews, brief physical and neurological examinations, blood draws and completion of self-report diaries. Volunteers can participate at no cost and will be compensated for their time.
Use of iPod Touch for Study Participants:
Women with epilepsy who are participating in the study will be given an iPod Touch and shown how to use the “women with epilepsy Pod” (WEPOD) application which will include a personalized seizure diary, medication diary, menstrual diary, and sexual activity log. The schedule of visits will be provided and programmed into their electronic calendar. The WEPOD application for women without epilepsy will include a menstrual diary and sexual activity log. For those participants who do not wish to use the iPod Touch, materials in paper formats will be provided with detailed instructions.
The participant will be asked to attend monthly visits, which will include visits at the clinical center and visits via telephone. All visits will include review of their adverse events, medication adherence, sexual activity, menstrual diary, and seizure diary for women with epilepsy. There will be additional visits for hormone and antiepileptic drug assessments for the first two months of the study. Home urine pregnancy tests will be provided and women will be instructed in their use. A participant will be instructed to conduct a pregnancy test if she reaches Day 35 of her cycle without menstrual flow. Once the participant is pregnant, she will have an initial pregnancy visit, and then visits will occur monthly for women with epilepsy until one month postpartum, and for women without epilepsy until one month postpartum.
For more information about the study or to see if you are eligible, call The Comprehensive Epilepsy Care Institute at 718-470-7310, or go to http://www.northshorelij.com/NSLIJ/Epilepsy+Centers.
About the Cushing Neuroscience Institutes (CNI):Part of the North Shore-LIJ Health System, the Cushing Neuroscience Institutes consist of multidisciplinary clinical and research teams that provide our patients with state-of-the-art treatments for the entire spectrum of neurological diseases, including brain aneurysms, AVM’s, stroke, traumatic brain injury, movement disorders, brain and spinal cord tumors, diseases of the spine, muscle and peripheral nerves, Chiari malformation, syringomyelia, neurodegenerative diseases, pain, epilepsy, and neurological diseases of infancy and childhood.
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