Early Pregnancy Sample Collection Study (EPS)

December 20, 2017 updated by: SPD Development Company Limited

Generic Protocol for the Collection of Early Pregnancy Urines

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4025

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK44 3UP
        • SPD Development Company Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPD Development Company Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROTOCOL-0400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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