Clearblue Advanced Fertility Monitor Consumer Three Cycle at Home Study

February 7, 2019 updated by: SPD Development Company Limited
This study will assess the use of the new Clearblue Advanced Fertility Monitor in a home setting for three menstrual cycles or until pregnancy is achieved (whichever comes first) by female volunteers seeking to get pregnant.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

The Clearblue Fertility Monitor is a personal monitor designed to be used with disposable test sticks for the semi-quantitative measurement of estrone-3-glucuronide (E3G) and luteinising hormone (LH) in women's urine. This personal information allows women to identify their fertile window and appropriately time intercourse in order to maximise their chances of conception. A new version of this monitor (Clearblue Advance Fertility Monitor) has been developed with enhanced functionality including the option to test for pregnancy.

This study will assess the use of the new Clearblue Advanced Fertility Monitor in a home setting by female volunteers seeking to become pregnant, for three menstrual cycles or until pregnancy is achieved (whichever comes first). This is a single centre clinical study which will be conducted by volunteers at their residence and co-ordinated by the clinical department at SPD Development Company Ltd.

The overall objective of the study will be to demonstrate the usage of the new Clearblue Advanced Fertility Monitor in a home setting, to assess the benefits of monitor usage and to compare monitor data to laboratory analyses on the same urine samples.

In order to achieve these objectives, a minimum of 200 female volunteers representing the target consumer will be recruited to use the new Clearblue Advanced Fertility Monitor at home as per the instructions for use. This will involve them setting up the monitor, using the monitor for the duration of the study..

All volunteers will be required to complete a daily diary and to collect a daily urine sample. Volunteers who become pregnant on the study will be asked to continue to collect urine samples. At the end of the study all volunteers will complete a study questionnaire which includes questions relating to monitor usage and knowledge and behaviour regarding conception. Upon return to SPD, the urine samples will be tested by auto-analyser for various hormones.

Study Type

Observational

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, MK43 7JX
        • 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 wishing to become pregnant

Description

Inclusion Criteria:

  • Female
  • Aged 18 - 45 years
  • Willing to provide written informed consent to participate in the study and comply to the investigational procedures
  • Naive to similar marketed products including current Clearblue Fertility Monitor and Persona
  • Two natural cycles immediately prior to entering the study, each lasting between 21 and 42 days
  • Seeking to become pregnant

Exclusion Criteria:

  • Employees of SPD, Proctor & Gamble or Alere
  • Have a condition that is known to be contra-indicated in pregnancy
  • Usually have menstrual cycles which are shorter than 21 days or longer than 42 days
  • Trying to conceive for12 months (for volunteers under 35) or trying to conceive for >6 months ( for volunteers 35 or older)
  • Using or have used in their last 2 cycles, hormonal contraceptives including oral, emergency oral, implants, patches, transdermal injections, vaginal ring and progesterone intrauterine systems (IUS)
  • Using or have used in the last 2 cycles, infertility medications or hormone replacement therapy containing hCG or LH
  • Taking clomiphene citrate or other ovulation induction drugs
  • Using any treatment which may affect the menstrual cycle
  • Have recently been pregnant, miscarried or breastfeeding
  • Have been diagnosed with polycystic ovarian syndrome (PCOS)
  • Are peri- or post-menopausal e.g. experiencing symptoms such as irregular menstrual periods, hot flushes, night sweats, sleep disturbances and mood swings
  • Are taking antibiotics containing tetracyclines
  • Have impaired liver or kidney function
  • Have previously participated in a SPD 'trying to conceive' study

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

Cohorts and Interventions

Group / Cohort
Fertility Monitor
Clearblue Fertility Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioural change
Time Frame: 3 months
To compare change in behaviour from self-reported baseline behaviour to that reported in daily diaries including intercourse frequency, personal fertility knowledge and pregnancy testing behaviour
3 months
Behavioural change
Time Frame: 3 months
To observe % compliance of conducting tests
3 months
User comprehension
Time Frame: 3 months
To assess user comprehension of the Instructions for use
3 months
Product performance
Time Frame: 3 months
To assess performance of the Clearblue Advanced Fertility Monitor at identification of fertile window in relation to quantitative LH and E3G measurements
3 months
product performance
Time Frame: 3 months
To compare pregnancy test results to quantitative hCG concentration
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioural change
Time Frame: 3 month
To examine pregnancy test results qualitative assessment of women's behaviour in monitor usage following early pregnancy loss, should this occur during the study
3 month
Pregnancy rate
Time Frame: 3 months
To examine pregnancy rate in relation to baseline demographics, intercourse pattern during the study and expected pregnancy rate based on published literature
3 months

Collaborators and Investigators

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

Sponsor

SPD Development Company Limited

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

Primary Completion (ACTUAL)

April 11, 2014

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

August 25, 2015

First Posted (ESTIMATE)

August 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROTOCOL-0682

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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