Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited
ClinicalTrials.gov Identifier:
NCT01084304
First received: March 9, 2010
Last updated: August 14, 2012
Last verified: September 2011
  Purpose

Approximately 150 female volunteers wishing to become pregnant will be recruited via web recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All volunteers will complete study questionnaires and provide a urine sample at designated time points though out the menstrual cycle.


Condition
Stress

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive

Further study details as provided by SPD Development Company Limited:

Primary Outcome Measures:
  • Cortisol Measurement [ Time Frame: Twice monthly ] [ Designated as safety issue: No ]
    Measurement of Urinary Cortisol throughout menstrual cycle


Biospecimen Retention:   Samples Without DNA

Urine samples


Estimated Enrollment: 150
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Active
Use of ovulation tests to aid conception
Control
No ovulation tests to aid conception

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Females aged 18 to 40 wishing to become pregnant

Criteria

Inclusion Criteria:

  • Provide written informed consent to participate in the study and agree to comply with study procedures.
  • Has menstrual bleeds.
  • Seeking to become pregnant.
  • Living in UK

Exclusion Criteria:

  • Used hormonal contraception within the last 3 months.
  • Currently undergoing fertility treatment or investigation.
  • Diagnosed as infertile following investigations.
  • Drug or alcohol dependency.
  • history of depression, anxiety or panic attacks
  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: NCT01084304

Locations
United Kingdom
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom, MK44 3UP
Sponsors and Collaborators
SPD Development Company Limited
Investigators
Principal Investigator: Sarah Johnson, Dr
  More Information

No publications provided by SPD Development Company Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01084304     History of Changes
Other Study ID Numbers: PROTOCOL-0172
Study First Received: March 9, 2010
Last Updated: August 14, 2012
Health Authority: UK: Ethics committee

Keywords provided by SPD Development Company Limited:
Pregnancy
Ovulation tests
stress
Wishing to become pregnant

ClinicalTrials.gov processed this record on July 20, 2014