Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT04667858
Eligibility Criteria:
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 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
* 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04667858
Study Brief:
Protocol Section:
NCT04667858