Fertility, Pregnancy
Conditions
Keywords
Trying to Conceive, Digital Home Ovulation Test, Usability
Brief summary
This study will assess the usability of a Digital 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 Digital 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 digital home ovulation test used to detect luteinising hormone (LH) and Estrone-3-Glucuronide (E3G) 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.
Interventions
DEVICEHome Ovulation Test
Digital read home ovulation test
Sponsors
SPD Development Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * Aged 18 to 45 years * Seeking to conceive * Willing to give informed consent and comply with the investigational procedures
Exclusion criteria
* Taking medication, or has known condition which means they should not get pregnant. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device usability | One menstrual cycle, average 28 days | The usability of the digital 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. |
Countries
United Kingdom
Outcome results
None listed