Clinical Performance Evaluation of INNOVITA LH Ovulation Rapid Test

• Conditions: Prediction of ovulation: Detection of human luteinizing hormone (LH) surge in urine

• Registration Number: DRKS00031332
• Lead Sponsor: INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-29
• Study Completion: 2023-12-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 345

Inclusion Criteria

females with age of 18-45
- Knowledge of cycle duration
- Agree to the utilization of their samples for processing, storage, analysis, documentation

Exclusion Criteria

- pregnant or breast-feeding
- women with Poly Cystic Ovary Syndrome (PCOS)
- Colour-impaired vision
- Use of hormonal contraception
- beginning of menopause
- Impaired cognitive function
- Lack of compliance
- Being a dependent of the sponsor/ investigator
- Medication intake (e.g. menotropins)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive Percent Agreement (PPA) in lieu of Diagnostic Sensitivity (DSens), Negative Percent Agreement (NPA) in lieu of Diagnostic Specificity (DSpec)

Secondary Outcome Measures

Name	Time	Method
Positive Predictive Value (PPV), Negative Predictive Value (NPV), Likelihood ratio (LR), Positive percent agreement (PPA) and Negative percent agreement (NPA) between laypersons and professionals