2. Materials and Methods
This pilot study used a prospective descriptive design. Institutional review board approval was obtained from the University. Study inclusion criteria for women are (1) between the ages of 18 and 42, (2) menstrual cycle length of 21 to 42 days, (3) had not used depot medroxyprogesterone acetate over the past 12 months, (4) had no history of oral or subdermal contraceptives for the past 3 months, (5) had at least three cycles past breastfeeding weaning, and (6) have no known fertility problems.The study participants were recruited through email using the Marquette NFP teacher network throughout North America. The teachers shared the study information with their clients, and the interested clients contacted the researchers. Women were pre-screened with questions based on the inclusion criteria using a simple survey. Thirty participants were recruited by this snowball method. After receiving informed consent, the participant was assigned a study ID and then randomized 1:1 into either the Premom LH test group or the EAH LH test group. All study participants were currently using the CBFM to track their ovulation to avoid pregnancy. Each Premom LH test group participant was provided with 60 Premom LH test strips and each EAH LH test group participant was provided 60 EAH LH test strips. Information was provided to the participants on how to download and use the Premom Ovulation Tracker app and urine testing. Participants were instructed to start testing their first morning urine void on day six of their menstrual cycle. They continued morning urine testing for 20 days with each menstrual cycle and for a total of three cycles. On the test morning, urine was collected in a clean container and the test strips from each monitoring system were placed in the urine for 15s consecutively (i.e., first the CBFM test strip and then right after the Premom or EAH test strip based on the group allocation). The participants recorded the low, high, and peak results for the CFBM and the quantitative results for the Premom LH test strip or the ratio result from the EAH LH test strip on their charting sheet.At the end of the third menstrual cycle, the participants completed a survey to evaluate user acceptability and satisfaction using the electronic fertility monitor. The survey was developed by Severy et al. [Descriptive statistics were calculated for participant demographics and the characteristics of the menstrual cycles. Independent t-tests were used to determine if there were differences between the Premom LH and EAH LH groups. Pearson correlation analysis was used to assess the correlation of the Premom peak LH level with the first CBFM peak day and the correlation of the EAH peak LH level with the first CBFM peak day. Paired t-tests were used to compare differences in ease of use and satisfaction for the CBFM, the Premom LH, or the EAH LH testing. 