Clearblue Advanced Fertility Monitor Consumer Three Cycle at Home Study
NCT ID: NCT02535260
Last Updated: 2019-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
OBSERVATIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
NCT01948258
Clearblue Home Pregnancy Test Consumer Study
NCT01279486
Early Pregnancy Sample Collection Study
NCT01577147
Continuous Sample Collection Study
NCT03719846
Consumer in Stream and Container Collected Study
NCT01577901
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fertility Monitor
Clearblue Fertility Monitor
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SPD Development Company Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PROTOCOL-0682
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.