PregnancyNCT04667858
Home Ovulation Test One Cycle at Home Study
An observational study of Pregnancy and Fertility, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
This study will assess the usability of a Home Ovulation Test when used at home by lay-users seeking to conceive. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Home Ovulation Test
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Dec 2020to 28 Apr 2021
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women seeking to conceive
Who may be able to join
- Female
- Aged 18 to 45 years
- Seeking to conceive
- Willing to give informed consent and comply with the investigational procedures
Who cannot join
- Taking medication, or has known condition which means they should not get pregnant.
- Currently pregnant or breastfeeding
- Used the test within the last six months
- Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
- Has an immediate* relative currently or previously (within past 5 years) employed by Swiss Precision Diagnostics (SPD), Abbott, Alere, Unipath or P\&G, or affiliates
- Immediate relatives are defined as parents, children, siblings or partner/spouse
Show all 14Show fewer
- Is a qualified or trainee healthcare professional (HCP)
- Has professional experience of using dipstick type tests or lateral flow devices
- Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
- Using infertility medications or hormone replacement medications containing Luteinising Hormone (LH) or human Chorionic Gonadotrophin (hCG) (e.g. Pregnyl®)
- Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI)
- Peri-or post-menopausal, e.g. experiencing symptoms: irregular menstrual periods, hot flushes, night sweats, sleep disturbances and/or moods swings
- Has been diagnosed with polycystic ovarian syndrome (PCOS)
- Has PCOS symptoms e.g. very irregular cycles, hirsutism
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP
About this study
This study will assess the usability of a Home Ovulation Test when used at home by lay-users seeking to conceive.
Read the detailed description
This study will assess the ease of use of a Home Ovulation Test when used by lay-users for one cycle in their home environment. The home ovulation test to be used in the study is a visual home ovulation test used to detect luteinising hormone (LH) in urine to identify when ovulation is imminent.
A sample size of 120 volunteers (minimum) will provide adequate information for assessing the usability of the home ovulation test. Usability of the test will be assessed through a questionnaire completed at the end of the study.
This observational study will be conducted remotely and volunteers representative of the intended user (lay-users) will be recruited.
- Being tested
- Home Ovulation Test
- Keywords
- Trying to Conceive, Home Ovulation Test, Usability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Ovulation TestDevice
Visual read home ovulation test
What is being measured
The primary outcome is the main question the study is designed to answer.
Device usability
The usability of the home ovulation test when used at home by volunteers seeking to conceive scored on a 7 point Likert scale where 1 is the lowest (most negative) score and 7 is the highest (most positive) score.
Measured: One menstrual cycle, average 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start22 Dec 2020
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Study director, SPD Development Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667858
- Sponsor's protocol ID
- PROTOCOL-1244
- Status last verified
- Apr 2021
- First submitted
- 8 Dec 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Ovulation Test One Cycle at Home Study
- ClinicalTrials.gov ID
- NCT04667858
- Acronym / sponsor ID
- PROTOCOL-1244
- Keywords
- Trying to Conceive, Home Ovulation Test, Usability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 16 Dec 2020 (actual)
- 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.
This study will assess the usability of a Home Ovulation Test when used at home by lay-users seeking to conceive.
Detailed description
This study will assess the ease of use of a Home Ovulation Test when used by lay-users for one cycle in their home environment. The home ovulation test to be used in the study is a visual home ovulation test used to detect luteinising hormone (LH) in urine to identify when ovulation is imminent.
A sample size of 120 volunteers (minimum) will provide adequate information for assessing the usability of the home ovulation test. Usability of the test will be assessed through a questionnaire completed at the end of the study.
This observational study will be conducted remotely and volunteers representative of the intended user (lay-users) will be recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women seeking to conceive
Key inclusion criteria (4 listed)
- Female
- Aged 18 to 45 years
- Seeking to conceive
- Willing to give informed consent and comply with the investigational procedures
Key exclusion criteria (14 listed)
- Taking medication, or has known condition which means they should not get pregnant.
- Currently pregnant or breastfeeding
- Used the test within the last six months
- Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
- Has an immediate* relative currently or previously (within past 5 years) employed by Swiss Precision Diagnostics (SPD), Abbott, Alere, Unipath or P\&G, or affiliates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Ovulation TestVisual read home ovulation test | Device | – |
Primary outcome
Device usability
Time frame: One menstrual cycle, average 28 days
The usability of the home ovulation test when used at home by volunteers seeking to conceive scored on a 7 point Likert scale where 1 is the lowest (most negative) score and 7 is the highest (most positive) score.
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 29 Apr 2021.
- Individual participant dataSharing planned: No
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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 study director
SPD Development Company
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 Pregnancy and Fertility, 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 14 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 29 Apr 2021. 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?
Device usability (time frame: One menstrual cycle, average 28 days). It is what the study was designed to measure, not a finding.
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 29 Apr 2021.