A comparison of the symptothermal cycle method using intravaginaltemperature measurement versus conventional temperature measurement - a retrospective cohort study
- Conditions
- Evaluation of the menstrual cycle based on the symptothermal method
- Registration Number
- DRKS00031801
- Lead Sponsor
- trackle GmbH
- Brief Summary
In conclusion, compared to the standardized manual analysis, an analysis of cycle data performed by women trained in the symptothermal method led to "bio-equivalent" results. However, slight non-significant differences were found in a minority of analyzed cycles and, thus, one can assume that this user-driven analysis might be somewhat less reliable. Noteworthy, the results confirm that the trackle algorithm leads to completely similar results as the standard manual analysis in evaluation of fertile days using the general principles of the symptothermal method. In other words, the trackle algorithm applies these complex rules correctly and reliably.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 25
Cycle length between 24 and 38 days before study kick-off
current therapy with contraceptives or ovarian stimulation with clomiphene, letrozole or follicle stimulating hormone and the unwillingness to provide electronic informed consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main aim of the study is to determine whether the trackle algorithm gives exactly the same results as the standardized, manual analysis for determining the fertile days using the principles of the symptothermal method. With the help of the trackle vaginal sensor and the user's information about her cervical mucus symptoms over the duration of 12 completed cycles, the time of ovulation is defined - once by the trackle algorithm, i.e. automatic and standardized, and once by two independent and experienced researchers using the symptothermal method.
- Secondary Outcome Measures
Name Time Method The results of the evaluation carried out by the trackle not only deliver the same results as the manual evaluation - the evaluation is also just as correct as the manual version of trained users and correctly depicts the corresponding physiological states in each cycle examined.