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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

A prospective observational study to evaluate the accuracy of a salivary ferning test (O’View-W) as a predictor of ovulation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0005700
Enrollment
85
Registered
2020-12-24
Start date
2021-05-12
Completion date
Unknown
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Korea Medical Device Development Fund
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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)—

Countries

Korea, Republic of

Contacts

Public ContactHyonsun An

Hanyang University Seoul Hospital

kulum67@naver.com+82-2-2290-8401

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026