Clinical trial NCT01948258: Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
Official title: Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2013-09-23
Enrollment: 395
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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:

* 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

Primary outcomes:
measure: The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting
timeFrame: one month use
Secondary outcomes:
measure: Correct Identification of Monitor Status
timeFrame: one month
Other outcomes:
measure: Pregnancy Test Result
timeFrame: one month
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Swiss Precision Diagnostics GmbH
name: Sarah Johnson, PhD
role: STUDY_DIRECTOR
References: