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
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COMPLETED
NA
4025 participants
INTERVENTIONAL
2012-01-31
2017-09-30
Brief Summary
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Detailed Description
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This generic study will be initiated to maintain the SPD sample bank, the study will run continuous to replenish the sample bank, as samples are used.
To obtain these samples, volunteers wishing to become pregnant will be offered the use of a Clearblue ovulation prediction product to enable them to pinpoint their most fertile time and aid conception. Whilst on the study volunteers will be asked to collect daily urine samples and return them to SPD on a regular basis in addition to keeping a daily record of menstrual cycle details and test results. Women who become pregnant during the course of the study will be asked to continue collecting daily urine samples for a minimum of a further 4 weeks. Each volunteer will be on the study for a minimum of 1 and a maximum of 3 cycles. Volunteers will not be allowed to re-enter the study once they have completed without achieving pregnancy
It is anticipated that any one of SPD's marketed ovulation prediction products may be used in this study to aid the conception rate, this may include, but not be limited to the Clearblue fertility monitor and Clearblue digital ovulation test.
It is anticipated SPD will have to recruit approximately 600 volunteers to achieve each 100 pregnancies and that approximately 500 volunteers will be participating at any one time. The study size may be increased or decreased to meet sample demands.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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sample collection
Ovulation prediction products provided to aid conception
Ovulation predictions products
Home diagnostics for ovulation prediction will be provided to study volunteers
Interventions
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Ovulation predictions products
Home diagnostics for ovulation prediction will be provided to study volunteers
Eligibility Criteria
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Inclusion Criteria
* Have menstrual bleeds
* Seeking to become pregnant
* Willing to provide written, informed consent
Exclusion Criteria
* Having treatment for infertility.
18 Years
45 Years
FEMALE
Yes
Sponsors
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SPD Development Company Limited
INDUSTRY
Responsible Party
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Locations
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SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom
Countries
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References
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Gadsby R, Ivanova D, Trevelyan E, Hutton JL, Johnson S. The onset of nausea and vomiting of pregnancy: a prospective cohort study. BMC Pregnancy Childbirth. 2021 Jan 6;21(1):10. doi: 10.1186/s12884-020-03478-7.
Johnson S, Marriott L, Zinaman M. Can apps and calendar methods predict ovulation with accuracy? Curr Med Res Opin. 2018 Sep;34(9):1587-1594. doi: 10.1080/03007995.2018.1475348. Epub 2018 May 25.
Other Identifiers
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PROTOCOL-0400
Identifier Type: -
Identifier Source: org_study_id