Home Ovulation Test One Cycle at Home Study | NCT04667858

Studies
Home Ovulation Test One Cycle at Home Study

NCT04667858

Sponsor

SPD Development Company Limited

Status

Completed

Last Update Posted

Apr 29, 2021Actual

Enrollment

121Actual

Phase

Not provided

Conditions

Pregnancy
Fertility

Interventions

Home Ovulation Test

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2020Actual

Primary Completion Date

Apr 28, 2021Actual

Completion Date

Apr 28, 2021Actual

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Dec 13, 2020

First Posted Date

Dec 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2021

Last Update Posted Date

Apr 29, 2021Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Name	Type	Description	Arm Group Labels	Other Names
Home Ovulation Test	Device	Visual read home ovulation test

Measure	Description	Time Frame
Device usability	The usability of the home ovulation test when used at home by volunteers seeking to conceive scored on a 7 point Likert scale where 1 is the lowest (most negative) score and 7 is the highest (most positive) score.	One menstrual cycle, average 28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Aged 18 to 45 years
Seeking to conceive
Willing to give informed consent and comply with the investigational procedures

Exclusion Criteria:

Taking medication, or has known condition which means they should not get pregnant.
Currently pregnant or breastfeeding
Used the test within the last six months
Currently or previously employed by SPD, Abbott, Alere, Unipath, P&G or affiliates
Has an immediate* relative currently or previously (within past 5 years) employed by Swiss Precision Diagnostics (SPD), Abbott, Alere, Unipath or P&G, or affiliates

*Immediate relatives are defined as parents, children, siblings or partner/spouse
Is a qualified or trainee healthcare professional (HCP)
Has professional experience of using dipstick type tests or lateral flow devices
Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
Using infertility medications or hormone replacement medications containing Luteinising Hormone (LH) or human Chorionic Gonadotrophin (hCG) (e.g. Pregnyl®)
Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI)
Peri-or post-menopausal, e.g. experiencing symptoms: irregular menstrual periods, hot flushes, night sweats, sleep disturbances and/or moods swings
Has been diagnosed with polycystic ovarian syndrome (PCOS)
Has PCOS symptoms e.g. very irregular cycles, hirsutism

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women seeking to conceive

Sampling Method

Probability Sample