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Early Pregnancy Sample Collection Study (EPS)

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ClinicalTrials.gov Identifier: NCT01577147
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Ovulation predictions products Not Applicable

Detailed 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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4025 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Generic Protocol for the Collection of Early Pregnancy Urines
Actual Study Start Date : January 2012
Actual Primary Completion Date : March 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
sample collection
Ovulation prediction products provided to aid conception
 Other: Ovulation predictions products
Home diagnostics for ovulation prediction will be provided to study volunteers


Outcome Measures
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Primary Outcome Measures :
  1. Collection of early pregnancy urine samples. [ Time Frame: 60 days ]
    Volunteers who become pregnant during the study will continue to collect daily urine samples until day 60 of the conception cycle.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577147


Locations
United Kingdom
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom, MK44 3UP
Sponsors and Collaborators
SPD Development Company Limited
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01577147     History of Changes
Other Study ID Numbers: PROTOCOL-0400
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: November 2016

Keywords provided by SPD Development Company Limited:
pregnancy