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Early Pregnancy Sample Collection Study (EPS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01577147
First Posted: April 13, 2012
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SPD Development Company Limited
  Purpose
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 Intervention
Pregnancy Other: Ovulation predictions products

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Generic Protocol for the Collection of Early Pregnancy Urines

Resource links provided by NLM:


Further study details as provided by SPD Development Company Limited:

Primary Outcome Measures:
  • 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.


Enrollment: 4025
Actual Study Start Date: January 2012
Estimated Study Completion Date: August 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sample collection
Ovulation prediction products provided to aid conception
Other: Ovulation predictions products
Home diagnostics for ovulation prediction will be provided to study volunteers

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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

Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01577147     History of Changes
Other Study ID Numbers: PROTOCOL-0400
First Submitted: April 11, 2012
First Posted: April 13, 2012
Last Update Posted: April 19, 2017
Last Verified: November 2016

Keywords provided by SPD Development Company Limited:
pregnancy