This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Early Pregnancy Sample Collection Study (EPS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
SPD Development Company Limited Identifier:
First received: April 11, 2012
Last updated: April 18, 2017
Last verified: November 2016
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: No masking
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.


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01577147

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 Identifier: NCT01577147     History of Changes
Other Study ID Numbers: PROTOCOL-0400
Study First Received: April 11, 2012
Last Updated: April 18, 2017

Keywords provided by SPD Development Company Limited:
pregnancy processed this record on June 22, 2017