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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: March 21, 2017
Last verified: March 2017
  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.

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
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 ]
    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   (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
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

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: March 21, 2017

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

ClinicalTrials.gov processed this record on June 28, 2017