Early Pregnancy Sample Collection Study (EPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited
ClinicalTrials.gov Identifier:
NCT01577147
First received: April 11, 2012
Last updated: September 18, 2013
Last verified: September 2013
  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: 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 ] [ Designated as safety issue: No ]
    Volunteers who become pregnant during the study will continue to collect daily urine samples until day 60 of the conception cycle.


Estimated Enrollment: 600
Study Start Date: January 2012
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: sample collection
no interventions in this sample collection study
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.

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 maximum of 3 cycles. Volunteers will not be allowed to re-enter the study once they have completed 3 cycles 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 100 pregnancies and that approximately 100 volunteers will be participating at any one time. The study size may be increased or decreased to meet sample demands.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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 ClinicalTrials.gov identifier: NCT01577147

Locations
United Kingdom
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom, MK44 3UP
Sponsors and Collaborators
SPD Development Company Limited
  More Information

No publications provided

Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01577147     History of Changes
Other Study ID Numbers: PROTOCOL-0400
Study First Received: April 11, 2012
Last Updated: September 18, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by SPD Development Company Limited:
pregnancy

ClinicalTrials.gov processed this record on September 16, 2014