Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study

This study will assess the use of the new Clearblue Advanced Fertility Monitor for one menstrual cycle in a home setting by female volunteers seeking to get pregnant.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Clearblue Advanced Fertility Monitor

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 Advanced Fertility Monitor) has been developed with additional functionality including the option to test for pregnancy.

This study will assess the volunteer ease of use of the new Clearblue Advanced Fertility Monitor and the understanding and interpretation of the results by the user. 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.

A minimum of 100 female volunteers representing the target consumer will be required 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 one full cycle and then setting up the monitor for their next cycle unless they test for pregnancy and get a pregnant result.

At the end of one full cycle, all volunteers will complete a study questionnaire which includes sections on comprehension of the instructions for use, ease of use and interpretation of test results.

• Study Type: Interventional
• Enrollment (Actual): 395
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bedfordshire
    • Bedford, Bedfordshire, United Kingdom, MK43 7JX
      • SPD Development Company Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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:

• Unwilling to provide written informed consent to participate in the study or comply with study procedures
• 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
• 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
• Are 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

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Clearblue Advanced Fertility Monitor; Use of Clearblue Fertility Monitor	Device: Clearblue Advanced Fertility Monitor; Clearblue Advanced Fertility Monitor used for one menstrual cycle in a home setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting	Acceptance criteria is that ≥80% of volunteers will score 3 or less on the Likert scale in a home setting by demonstrating ease of use and comprehension of the instructions for use.	one month use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct Identification of Monitor Status	To demonstrate correct user identification of fertility status and test days and to determine the performance of the monitor in consumer hands.	one month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy Test Result	Pregnancy test results will also be compared with both the performance of a currently marketed pregnancy test when used by a trained technician and quantitative hCG concentration.	one month

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Investigators: Study Director: Sarah Johnson, PhD, SPD Swiss Precision Diagnostics GmbH

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: September 18, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (ESTIMATE): September 23, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy
• Other Study ID Numbers: 0481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Overall results will be shared after study completion