None listed
Conditions
Interventions
Intervention1: Semen detection Kit: To Assess the accuracy of the SD Kit by evaluating its sensitivity and specificity in detecting semen
in vaginal swab samples for duration of 1 day
Control Interve
Sponsors
Human Biogenesis Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Sexually active females aged 18-35 years. 2.Willing to provide vaginal swab samples at specified time interval (24 hours) after consensual sexual intercourse. 3.Able to provide informed consent.
Exclusion criteria
Exclusion criteria: 1.Known acute vaginal infections (e.g bacterial vaginosis, candidiasis) within the past 30 days. 2.Participation in another clinical trial or study within the past 30 days may confound the results of this study. 3.Pregnancy or lactation at the time of enrollment. 4.Recent use of vaginal medications, creams, or suppositories within the past 7 days. 5.History of chronic medical conditions affecting vaginal health (e.g., recurrent urinary tract infections, pelvic inflammatory disease). 6. History of recent vaginal surgery or procedures that could interfere with sample collection or interpretation. 7.Inability to comply with study procedures or follow-up visits. 8.Any medical condition or treatment that, in the opinion of the investigator, could compromise the participants safety or the integrity of the study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To check the Sensitivity and Specificity of the SD Kit in distinguishing between the presence or absence of semen in the collected samples.Timepoint: 2 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive Predictive Value (PPV) and Negative Predictive Value (NPV) to measure the SD Kits accuracy in identifying true positive or negative results.Timepoint: 2 Days | — |
Countries
India
Contacts
Public ContactDivya Chandradhar
BioAgile therapeutics Private Limited
Outcome results
None listed