Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study

Not Applicable

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Clearblue Advanced Fertility Monitor	Clearblue Advanced Fertility Monitor	Use of Clearblue Fertility Monitor

Primary Outcome Measures

Name	Time	Method
The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting	one month use	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.

Secondary Outcome Measures

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