Status:
COMPLETED
Digital Home Ovulation Test One Cycle at Home Study
Lead Sponsor:
SPD Development Company Limited
Conditions:
Pregnancy
Fertility
Eligibility:
FEMALE
18-45 years
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 hom...
Eligibility Criteria
Inclusion
- Female
- Aged 18 to 45 years
- Seeking to conceive
- Willing to give informed consent and comply with the investigational procedures
Exclusion
- 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
Key Trial Info
Start Date :
December 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 22 2021
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04667845
Start Date
December 22 2020
End Date
April 22 2021
Last Update
April 29 2021
Active Locations (1)
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1
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom, MK44 3UP