Clinical trial NCT04667845: Digital Home Ovulation Test One Cycle at Home Study
Official title: Digital Home Ovulation Test One Cycle at Home Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Fertility
Keywords: Trying to Conceive
Digital Home Ovulation Test
Usability
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2020-12-16
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women seeking to conceive

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.

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 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

Primary outcomes:
measure: Device usability
timeFrame: One menstrual cycle, average 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development Company
name: Sarah Johnson
role: STUDY_DIRECTOR
References: