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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084304
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : March 24, 2017
Information provided by (Responsible Party):
SPD Development Company Limited

Brief Summary:

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.

A sub-arm to this study, applied the same protocol to women in an infertility treatment setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe male-factor infertility (with <5 million motile sperm per ejaculate). For this arm, the protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.

Condition or disease

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
Study Start Date : February 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Use of ovulation tests to aid conception
No ovulation tests to aid conception

Primary Outcome Measures :
  1. Cortisol Measurement [ Time Frame: Twice monthly ]
    Measurement of Urinary Cortisol throughout menstrual cycle

Biospecimen Retention:   Samples Without DNA
Urine samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Females aged 18 to 40 wishing to become pregnant

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01084304

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: SPD Development Company Limited Identifier: NCT01084304     History of Changes
Other Study ID Numbers: PROTOCOL-0172
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017

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