2 Clinical Trials for Various Conditions
The study is a prospective, 1-arm, open label, nonrandomized, single center study designed to evaluate label comprehension, device usability and safety of the FERTI·LILY Conception Cup. The primary safety endpoint will be an assessment of reported adverse events. Subjects will be screened -10 (±3) days prior to the baseline visit. At baseline, 15-20 subjects meeting the inclusion/exclusion criteria will be provided with a FERTI·LILY Conception Cup device and instructions for using the device. Subjects will participate in a label comprehension protocol that includes the physician confirmation that they have adequate comprehension to enroll. If not, a screen failure form is completed. Subjects will agree to try and use the device within 2 weeks of disposition therefore at baseline a two-week visit is scheduled. In the event they do not use the device within the two-week period the follow up visit can be rescheduled based on the visit window of +14 days. If it is not used within 4 weeks, the PI will have the subject return to the site to authorize another two-week period that will be captured as unscheduled follow up visit. The subject should complete the Device Experience Survey after each device use. The Device Experience Survey will be returned at this time, and adverse events will be assessed.
Background: The North Carolina Early Pregnancy Study (EPS) was held from 1982 to 1986. Women who were trying to get pregnant took part in the study. They collected urine samples. They kept diaries. They filled out surveys. They answered questions about their partners. They were asked about their drug use. Data about air pollution and other exposures were also collected. A follow-up study was held from 2010 to 2011. Researchers want to use the data and samples to study factors that affect reproductive success. Objective: To examine behavioral and environmental exposures and reproductive health, such as menstrual cycles, conception, pregnancy loss, and pregnancy outcomes. Eligibility: The 221 healthy women age 21-42 who were planning to get pregnant and took part in the 1982-86 North Carolina EPS at the time they stopped using all birth control. A 2010-11 follow-up included 173 of these women. Design: This study uses existing data. No new data will be collected in this study. Stored urine samples may be used. Data from surveys and other sources will be used. All of the women who gave data and samples will be included. Electronic data is held in secure databases. The data is kept on computers that are password protected. Hard-copy data are stored in locked file cabinets. The study will take place at more than one site. Data will be shared with groups outside the NIH....