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

March 21, 2017 updated by: SPD Development Company Limited

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK44 3UP
        • SPD Development Company Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Females aged 18 to 40 wishing to become pregnant

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Active
Use of ovulation tests to aid conception
Control
No ovulation tests to aid conception

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol Measurement
Time Frame: Twice monthly
Measurement of Urinary Cortisol throughout menstrual cycle
Twice monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPD Development Company Limited

Investigators

  • Principal Investigator: Sarah Johnson, Dr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROTOCOL-0172

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe