Home Ovulation Test One Cycle at Home Study

April 28, 2021 updated by: SPD Development Company Limited
This study will assess the usability of a Home Ovulation Test when used at home by lay-users seeking to conceive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK44 3UP
        • SPD Development Company Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women seeking to conceive

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device usability
Time Frame: One menstrual cycle, average 28 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPD Development Company Limited

Investigators

  • Study Director: Sarah Johnson, SPD Development Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 22, 2020

Primary Completion (ACTUAL)

April 28, 2021

Study Completion (ACTUAL)

April 28, 2021

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 13, 2020

First Posted (ACTUAL)

December 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROTOCOL-1244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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