Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT04667858
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2020-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home Ovulation Test One Cycle at Home Study
Sponsor:
SPD Development Company Limited
Organization:
Study Overview
Official Title:
Home Ovulation Test One Cycle at Home Study
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the usability of a 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 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 visual home ovulation test used to detect luteinising hormone (LH) 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: