NCT04667845

Digital Home Ovulation Test One Cycle at Home Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: SPD Development Company Limited · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will assess the usability of a Digital Home Ovulation Test when used at home by lay-users seeking to conceive.

Detailed description

This study will assess the ease of use of a Digital Home Ovulation Test when used by lay-users for one cycle in their home environment. The home ovulation test to be used in the study is a digital home ovulation test used to detect luteinising hormone (LH) and Estrone-3-Glucuronide (E3G) in urine to identify when ovulation is imminent. A sample size of 120 volunteers (minimum) will provide adequate information for assessing the usability of the home ovulation test. Usability of the test will be assessed through a questionnaire completed at the end of the study. This observational study will be conducted remotely and volunteers representative of the intended user (lay-users) will be recruited.

Conditions

• Pregnancy
• Fertility

Interventions

Type	Name	Description
DEVICE	Home Ovulation Test	Digital read home ovulation test

Timeline

• Start date: 2020-12-22
• Primary completion: 2021-04-22
• Completion: 2021-04-22
• First posted: 2020-12-16
• Last updated: 2021-04-29

Locations

1 site across 1 country: United Kingdom