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Real-world validation of a bleeding prediction algorithm in levonorgestrel intrauterine device users using the MyIUS
Carolina Sales Vieira1, Lisa Eggebrecht2, Igor Andre Milhoranca2
1Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo, Brazil.
Contraception
|September 6, 2025
Summary
The MyIUS app accurately predicts bleeding intensity in users of levonorgestrel intrauterine devices (LNG-IUDs). While effective for intensity, further improvements are needed for predicting menstrual cycle regularity.
Area of Science:
- Contraception and Reproductive Health
- Digital Health and Mobile Applications
- Real-World Evidence Studies
Background:
- Levonorgestrel-releasing intrauterine devices (LNG-IUDs) are widely used for contraception and managing abnormal uterine bleeding.
- Understanding and predicting bleeding patterns post-insertion is crucial for user satisfaction and adherence.
- Mobile health applications offer a promising avenue for personalized health insights.
Purpose of the Study:
- To validate the real-world performance of the MyIUS mobile application algorithm in predicting bleeding intensity and regularity.
- To assess the algorithm's accuracy across different dosages of levonorgestrel intrauterine devices (LNG-IUDs).
- To provide evidence supporting the global use of MyIUS for individualized bleeding insights.
Main Methods:
- An observational, real-world performance study involving participants in Germany, Denmark, Sweden, Spain, Mexico, and Brazil.
- Inclusion of women aged 18+ using MyIUS app for 90 days post-LNG-IUD insertion (52 mg, 19.5 mg, or 13.5 mg).
- Comparison of 90-day predicted bleeding profiles (intensity and regularity) with self-reported bleeding data over the subsequent 180 days.
Main Results:
- The algorithm demonstrated sufficient discrimination for bleeding intensity prediction with a multiclass AUC of 0.81 (95% CI, 0.79-0.83).
- The prediction of menstrual cycle regularity showed a lower performance with an overall AUC of 0.66 (95% CI, 0.63-0.68).
- Data from 1,734 participants with near-complete datasets were analyzed.
Conclusions:
- The MyIUS algorithm's bleeding intensity prediction is validated in a real-world setting.
- The findings support the global application of MyIUS for personalized insights into bleeding changes after LNG-IUD insertion.
- Further algorithm refinement for cycle regularity prediction and clinical utility testing are recommended.
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