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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
History of Changes
  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
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

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 May 23, 2013