Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
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|ClinicalTrials.gov Identifier: NCT01084304|
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : March 24, 2017
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|
|Official Title:||Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Use of ovulation tests to aid conception
No ovulation tests to aid conception
- Cortisol Measurement [ Time Frame: Twice monthly ]Measurement of Urinary Cortisol throughout menstrual cycle
Biospecimen Retention: Samples Without DNA
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 ClinicalTrials.gov identifier (NCT number): NCT01084304
|SPD Development Company Ltd|
|Bedford, Bedfordshire, United Kingdom, MK44 3UP|
|Principal Investigator:||Sarah Johnson, Dr|