Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
125 participants
OBSERVATIONAL
2020-12-22
2021-04-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Home Ovulation Test
Digital read home ovulation test
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 45 years
* Seeking to conceive
* Willing to give informed consent and comply with the investigational procedures
Exclusion Criteria
* Currently pregnant or breastfeeding
* Used the digital ovulation test within the last six months
* Currently or previously employed by Swiss Precision Diagnostics (SPD), Abbott, Alere, Unipath, P\&G or affiliates
* Has an immediate\* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G, or affiliates
\*Immediate relatives are defined as parents, children, siblings or partner/spouse
* 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
* Has abnormal liver or kidney function
* Is taking antibiotics containing tetracycline
18 Years
45 Years
FEMALE
Yes
Sponsors
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SPD Development Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah Johnson
Role: STUDY_DIRECTOR
SPD Development Company
Locations
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SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom
Countries
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Other Identifiers
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PROTOCOL-1200
Identifier Type: -
Identifier Source: org_study_id
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