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NCT01084304 Clinical Trial

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

Stress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01084304
Other study ID # PROTOCOL-0172
Secondary ID
Status Completed
Phase N/A
First received March 9, 2010
Last updated March 21, 2017
Start date February 2010
Est. completion date June 2011

Study information
Verified date March 2017
Source SPD Development Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom SPD Development Company Ltd Bedford Bedfordshire

Sponsors (1)
Lead Sponsor Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cortisol Measurement Measurement of Urinary Cortisol throughout menstrual cycle Twice monthly
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