Prospective observation test to evaluate the accuracy by measuring the ovulation cycle of a bodily fluid analyzer (smart ovulation test O'View-W) using saliva and measuring the ovulation cycle by comparing it with the hospital vaginal ultrasound result
Not Applicable
- Conditions
- Not Applicable
- Registration Number
- KCT0005700
- Lead Sponsor
- Korea Medical Device Development Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 85
Inclusion Criteria
1) Women of healthy childbearing age with a constant menstrual cycle of 25 to 35 days for the last 3 months
2) Those who read, understand, and can agree to the consent form
3) Adults over 19 years old
Exclusion Criteria
1) Pregnant or lactating women
2) Menopausal women
3) Those who use hormonal contraceptives or intrauterine contraceptives
4) If it is determined that it is not suitable for participation in the research by the judgment of other researchers
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity (%): When there is signs of ovulation as a result of a hard ultrasound test, the probability that the result of the O-View-W test will also be evaluated as fertile Specificity (%): When there is no signs of ovulation as a result of hard ultrasound, the probability of being evaluated as non-fertile or transitional as a result of the O-View-W test Positive predictive value (%): Probability of signs of ovulation as a result of transvaginal ultrasound when evaluated as fertile as a result of Oview-W test Negative predictive value (%): Probability of no signs of ovulation as a result of hard ultrasound when evaluated as non-fertile or transitional as a result of Oview-W test Accuracy (%):(True positive + True negative)/(True positive + True negative + False positive + False negative)
- Secondary Outcome Measures
Name Time Method ot applicable