InfertilityNCT01364935
Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors
An observational study of Infertility, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Comparative study to determine whether several fertility monitoring products - the DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the DuoFertility monitor. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to May 2014
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female participants trying to conceive, with regular menstrual cycles.
Who may be able to join
- Participant is willing and able to give informed consent for participation
- Females aged 18 to 44 years
- Have a body mass index (BMI) above 19 and below 29
- Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months
- Minimum menstrual cycle 24 days
- Maximum menstrual cycle 33 days
- Female participants willing to use the 3 fertility monitors for at least 3 cycles.
- Willing to fill in regular questionnaires and study diaries
Who cannot join
- Women aged younger than 18 years, or older than 44 years
- Have a BMI less than 18 or greater than 29
- Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases
- Polycystic ovary disease
- Endometriosis or other pelvic pathology (including proven tubal disease)
- Taking steroids, including oral contraceptives or anti inflammatory drugs
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application
Comparative study to determine whether several fertility monitoring products - the DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the DuoFertility monitor.
Read the detailed description
The investigators plan to recruit 30 women who are currently trying to conceive, and ask them to use the 3 fertility monitors for duration of 3 menstrual cycles. Additionally, during the study the women will be asked to fill in online questionnaires to assess the usability of the monitors. As the spouse is often a critical partner in the purchase decision and compliance, the investigators will also ask the spouse to complete similar online questionnaires.
- Conditions
- Infertility
- Medical subject headings
- Infertility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Temperature Concepts
- Responsible party
- Principal investigator, Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Basil Matta, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364935
- Sponsor's protocol ID
- A092165
- Other IDs
- 11/EE/0016
- Status last verified
- Jun 2014
- First submitted
- 31 May 2011
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application
- ClinicalTrials.gov ID
- NCT01364935
- Acronym / sponsor ID
- A092165
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Cambridge Temperature Concepts
- Study start
- Mar 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Jun 2011 (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.
Comparative study to determine whether several fertility monitoring products - the DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the DuoFertility monitor.
Detailed description
The investigators plan to recruit 30 women who are currently trying to conceive, and ask them to use the 3 fertility monitors for duration of 3 menstrual cycles. Additionally, during the study the women will be asked to fill in online questionnaires to assess the usability of the monitors. As the spouse is often a critical partner in the purchase decision and compliance, the investigators will also ask the spouse to complete similar online questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female participants trying to conceive, with regular menstrual cycles.
Key inclusion criteria (8 listed)
- Participant is willing and able to give informed consent for participation
- Females aged 18 to 44 years
- Have a body mass index (BMI) above 19 and below 29
- Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months
- Minimum menstrual cycle 24 days
Key exclusion criteria (6 listed)
- Women aged younger than 18 years, or older than 44 years
- Have a BMI less than 18 or greater than 29
- Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases
- Polycystic ovary disease
- Endometriosis or other pelvic pathology (including proven tubal disease)
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
Not reported in the source record.
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 25 Jun 2014.
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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.
Basil Matta principal investigator
Cambridge University Hospitals NHS Foundation Trust
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 Infertility, run by Cambridge University Hospitals NHS Foundation Trust 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 8 inclusion and 6 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 25 Jun 2014. 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.
Where can I read the original study information?
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 25 Jun 2014.