NCT03424590

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2018

Completed
Last Updated

October 19, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

January 25, 2018

Last Update Submit

October 18, 2018

Conditions

Pregnancy

Outcome Measures

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

    2 months

Secondary Outcomes (2)

  • Assessment of behaviour of women trying to conceive

    2 months

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

    2 months

Study Arms (2)

COTS

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Clearblue Connected Ovulation Test SystemDEVICE

Urinary LH test to predict ovulation

COTS

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35136878DERIVED

Study Officials

  • Sarah Johnson, Dr

    SPD Development Company Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 7, 2018

Study Start

January 29, 2018

Primary Completion

September 19, 2018

Study Completion

September 19, 2018

Last Updated

October 19, 2018

Record last verified: 2018-07

Locations

GB(1)