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CompletedNCT03424590Updated Oct 19, 2018

Connected Ovulation Test Efficacy Study

An interventional study of Clearblue Connected Ovulation Test System in Pregnancy, sponsored by SPD Development Company Limited. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-19.

Sponsored by SPD Development Company Limited (part of SPD Swiss Precision Diagnostics GmbH) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who are either planning or trying for a pregnancy. This study will determine the difference in pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to those not using an ovulation product to assist with conception.

02

Conditions studied

  • Pregnancy
03

In context

Lead sponsor

SPD Development Company Limited is the lead sponsor of 31 studies on the registry; 1 is open to participants now.

Browse SPD Development Company Limited studies →All SPD Swiss Precision Diagnostics GmbH studies →

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Actively trying to conceive
  • At least 2 regular consecutive cycles since last pregnancy/ miscarriage/ or since stopping breastfeeding
  • Willing to use their own smartphone for the duration of this study and to download and install the study app
  • Willing to disclose their pregnancy status and provide urine samples to test markers related to pregnancy and fertility
  • Have internet access on their phone for the duration of the study
  • Willing to give informed consent and comply with the investigational procedures

Exclusion criteria

Exclusion Criteria:

  • Currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G, or affiliates
  • Has an immediate relative* currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G or affiliates
  • There is a reason why the volunteer should not get pregnant e.g. they are taking a medication or have a medical condition which means they should not get pregnant
  • Trying to conceive for more than 6 months (if less than 35 years old) and more than 3 months (if 35 years old or over)
  • Has been diagnosed with Polycystic Ovarian Syndrome (PCOS)
  • Has PCOS symptoms: very irregular cycles, hirsutism
  • Using or has previously used infertility medications or hormone replacement therapy containing hCG or LH (e.g Pregnyl)
  • Are taking clomiphene citrate or other ovulation induction drugs
  • Using any treatment which may affect the menstrual cycle (e.g. the contraceptive pill)
  • Currently pregnant or breastfeeding
  • Peri- or post-menopausal, e.g. experiencing symptoms: Irregular menstrual periods, hot flushes, night sweats, sleep disturbances, and mood swings
  • Have abnormal liver or kidney function
  • Taking medication containing tetracycline
  • Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as IVF or ICSI
  • Has a phone that is known to be incompatible with COTS
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (actual)

Study arms

  • Active comparator
    COTS

    Volunteers will be provided with Clearblue connected Ovulation test system to use during the study period, accortding to the instructions for use.

    Device: Clearblue Connected Ovulation Test System

  • No intervention
    Control

    Volunteers will not be provided with Clearblue Connected Ovulation Test System and will be instructed not to use any other ovulation predictions tests during the study period.

Interventions

  • DeviceClearblue Connected Ovulation Test System

    Urinary LH test to predict ovulation

06

What researchers measure

Primary outcomes

  1. Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention.

    The difference in pregnancy rates between volunteers trying to conceive in the home setting using (i) COTS (ii) no intervention

    Time frame: 2 months

Secondary outcomes

  1. Assessment of behaviour of women trying to conceive

    Quantitative assessment in methods used to try and help with conception and intercourse patterns.

    Time frame: 2 months

  2. Evaluation of women's experience of trying to conceive using COTS compared to not using ovulation tests

    Qualitative interview responses regarding usage and experience of COTS or other methods whilst trying to conceive.

    Time frame: 2 months

07

Study locations

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

References and documents

Publications

  • Johnson S, Bond S, Grace B, Marriott L. Increased Chance of Live Birth Following Use of Connected Ovulation Test System: Outcome Results from a Randomized Controlled Trial. Womens Health Rep (New Rochelle). 2022 Jan 31;3(1):60-66. doi: 10.1089/whr.2021.0102. eCollection 2022. PubMed 35136878 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03424590
Lead sponsor
SPD Development Company Limited
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Jan 29, 2018
Primary completion
Sep 19, 2018
Completion
Sep 19, 2018
Last update
Oct 19, 2018

Study contacts

Sarah Johnson, Dr
study director · SPD Development Company Ltd.

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 Jul 2018. You cannot join it, but the record below documents what was studied.

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