Clearblue Advanced Fertility Monitor Consumer Three Cycle at Home Study

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Clearblue Advanced Fertility Monitor Consumer Three Cycle at Home Study

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fertility Monitor<br>Clearblue Fertility Monitor | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural change | 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 | To observe % compliance of conducting tests | 3 months | 
| User comprehension | To assess user comprehension of the Instructions for use | 3 months | 
| Product performance | 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 | To compare pregnancy test results to quantitative hCG concentration | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural change | 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 | To examine pregnancy rate in relation to baseline demographics, intercourse pattern during the study and expected pregnancy rate based on published literature | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy