Early Pregnancy Sample Collection Study
This trial is active, not recruiting.
|Treatment||ovulation predictions products|
|Sponsor||SPD Development Company Limited|
|Start date||January 2012|
|End date||March 2016|
|Trial size||4025 participants|
|Trial identifier||NCT01577147, PROTOCOL-0400|
Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation prediction products to help identify their most fertile time and aid conception. Volunteers will provide SPD with a daily urine sample throughout the study period, which will be used for the development and validation of SPD products related to pregnancy and fertility.
|Intervention model||single group assignment|
|Primary purpose||basic science|
Ovulation prediction products provided to aid conception
Collection of early pregnancy urine samples.
time frame: 60 days
Female participants from 18 years up to 45 years old.
Inclusion Criteria: - Female, age 18-45 - Have menstrual bleeds - Seeking to become pregnant - Willing to provide written, informed consent Exclusion Criteria: - Known condition to contra-indicate pregnancy - Having treatment for infertility.
|Official title||Generic Protocol for the Collection of Early Pregnancy Urines|
|Description||In order to develop and validate new and existing products SPD needs to maintain a sample bank of early pregnancy urine samples from the beginning of the cycle in which pregnancy is achieved, and throughout pregnancy. 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.|
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