StressNCT01084304
Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
An observational study of Stress, run by SPD Development Company Limited at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females aged 18 to 40 wishing to become pregnant
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP
About this study
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.
- Conditions
- Stress
- Keywords
- Pregnancy, Ovulation tests, stress, Wishing to become pregnant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active | Use of ovulation tests to aid conception | |
| Control | No ovulation tests to aid conception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol Measurement
Measurement of Urinary Cortisol throughout menstrual cycle
Measured: Twice monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084304
- Sponsor's protocol ID
- PROTOCOL-0172
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2010
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones G, Carlton J, Weddell S, Johnson S, Ledger WL. Women's experiences of ovulation testing: a qualitative analysis. Reprod Health. 2015 Dec 21;12:116. doi: 10.1186/s12978-015-0103-y.
PubMed 26689590Tiplady S, Jones G, Campbell M, Johnson S, Ledger W. Home ovulation tests and stress in women trying to conceive: a randomized controlled trial. Hum Reprod. 2013 Jan;28(1):138-51. doi: 10.1093/humrep/des372. Epub 2012 Oct 18.
PubMed 23081872
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
- ClinicalTrials.gov ID
- NCT01084304
- Acronym / sponsor ID
- PROTOCOL-0172
- Conditions
- Stress
- Keywords
- Pregnancy, Ovulation tests, stress, Wishing to become pregnant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | – | –Use of ovulation tests to aid conception |
| Control | – | –No ovulation tests to aid conception |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females aged 18 to 40 wishing to become pregnant
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cortisol Measurement
Time frame: Twice monthly
Measurement of Urinary Cortisol throughout menstrual cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Derived from this study: PubMed 26689590Jones G, Carlton J, Weddell S, Johnson S, Ledger WL. Women's experiences of ovulation testing: a qualitative analysis. Reprod Health. 2015 Dec 21;12:116. doi: 10.1186/s12978-015-0103-y.
- Derived from this study: PubMed 23081872Tiplady S, Jones G, Campbell M, Johnson S, Ledger W. Home ovulation tests and stress in women trying to conceive: a randomized controlled trial. Hum Reprod. 2013 Jan;28(1):138-51. doi: 10.1093/humrep/des372. Epub 2012 Oct 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Johnson, Dr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by SPD Development Company Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol Measurement (time frame: Twice monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01084304, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.