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CompletedNCT04667845Updated Apr 29, 2021

Digital Home Ovulation Test One Cycle at Home Study

An observational study in Pregnancy and Fertility, sponsored by SPD Development Company Limited. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-29.

Sponsored by SPD Development Company Limited · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
125
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

This study will assess the usability of a Digital Home Ovulation Test when used at home by lay-users seeking to conceive.

Read the 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.

02

Conditions studied

  • Pregnancy
  • Fertility

Keywords

  • Trying to Conceive
  • Digital Home Ovulation Test
  • Usability
03

In context

Lead sponsor

SPD Development Company Limited is the lead sponsor of 30 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Women seeking to conceive

Inclusion criteria

  • Female
  • Aged 18 to 45 years
  • Seeking to conceive
  • Willing to give informed consent and comply with the investigational procedures

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
125 participants (actual)
Patient registry
No

Interventions

  • DeviceHome Ovulation Test

    Digital read home ovulation test

06

What researchers measure

Primary outcomes

  1. Device usability

    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.

    Time frame: One menstrual cycle, average 28 days

07

Study locations

1 site
  • SPD Development Company Ltd
    Bedford, Bedfordshire MK44 3UP, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04667845
Lead sponsor
SPD Development Company Limited
Responsible party
Sponsor
First posted
Dec 16, 2020
Start date
Dec 22, 2020
Primary completion
Apr 22, 2021
Completion
Apr 22, 2021
Last update
Apr 29, 2021

Study contacts

Sarah Johnson
study director · SPD Development Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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