Clinical Performance Evaluation of INNOVITA LH Ovulation Rapid Test

Clinical Performance Evaluation of INNOVITA LH Ovulation Rapid Test - REQA_23001_INNO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031332

Enrollment

300

Registered

2023-03-29

Start date

2023-04-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

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

Interventions

Group 1: Testing of urine samples with the investigational device (INNOVITA LH Ovulation Rapid Test). Testing of the three models (Strip, Midstream, Cassette) with 100 patients each. The urine sample

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Positive Percent Agreement (PPA) in lieu of Diagnostic Sensitivity (DSens), Negative Percent Agreement (NPA) in lieu of Diagnostic Specificity (DSpec)	—

Secondary

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

Countries

Germany

Contacts

Public ContactHakan Inan

Requalite GmbH

Hakan@requalite.com+498932800304

Outcome results

None listed

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