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OpenTrials
Completed

NCT Number: NCT01084304

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cortisol Measurement

    Time frame: Twice monthly

    Measurement of Urinary Cortisol throughout menstrual cycle

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2010
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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