Ovulation Egg release
Conditions
Interventions
The investigational product is the Danae Vida, a reusable, transient-invasive vaginal sensor designed for daily self-use (~90 s). It simultaneously records:Basal body temperature (BBT)Cervical mucus c
participants continue their usual lifestyle.
Sponsors
Danae Netherlands
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Female, aged between 18 and 43Natural menstrual cycle (not hormonally suppressed), with a duration of 24 to 40 daysWilling to participate for a minimum of three complete menstrual cyclesCognitively capable of following study instructionsAble to understand and complete Dutch-language questionnairesAccess to and ability to operate a smartphone compatible with the study application.
Exclusion criteria
Exclusion criteria: Planning for achieving pregnancy within 6 monthsPrior clinical diagnosis of infertilityKnown morbidities such as cancer and/or diseases affecting reproductive organs. History of pregnancy in the last three monthsCurrently breastfeeding Use of any contraceptive medication within the last two months.End-stage disease or terminal illness.Known allergy or hypersensitivity to any of the materials used in the Danae Vida device, including gold, silver, stainless steel, barium titanate (BaTiO3), white PLA, BioMed White Resin (2201601), Loctite 4011, Loctite EA M-31CL, silicone, or Viton (fluoroelastomer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the accuracy of the Danae Vida device in estimating the day of ovulation, operationalized as its construct validity against the Reference Standard, which is defined as the combination of transvaginal ultrasound and urinary LH surge testing with the Clearblue Digital Ovulation Test (Swiss Precision Diagnostics GmbH, Geneva, Switzerland). Construct validity will be evaluated using the intra-class correlation coefficient (ICC) for absolute agreement, using a two-way mixed-effects model. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the Intraclass Correlation Coefficient (ICC), an additional clinical outcome measure will be included: the proportion of menstrual cycles for which the Danae Vida device predicts the ovulation day within ±1 day of the Reference Standard. A proportion of =90 % will be considered clinically acceptable, with a minimum acceptable threshold of =75 %, consistent with a non-inferiority design. This outcome will be evaluated both per participant and at group level across all analyzable cycles. The following other study parameers are gathered: Baseline characteristics (age, body weight, smoking status, menstrual cycle length, prior pregnancies, medical history) will be summarized descriptively using appropriate statistics (means, SDs, counts, percentages). Device input variables such as BBT, cervical mucus properties (spinnbarkeit, viscosity, im-pedance, colour, transparency), and vaginal wall blood volume pulse will also be reported descriptively. These data will support algorithm refinement but are not used in primary analysis. Feasibility and usability parameters collected during Phase 1 will be analyzed descriptively: - Questionnaire responses (Likert/NRS) will be summarized with medians, IQRs, and frequencies. - Adherence will be reported as the proportion of completed daily measurements per participant. - Predefined thresholds will guide decisions on progression to Phase 2. | — |
Countries
Netherlands
Contacts
Public ContactM.T. Franken
Kinetic Analysis B.V.
Outcome results
None listed