Connected Ovulation Test Efficacy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-29

Study Completion Date

2018-09-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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COTS

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

Group Type ACTIVE_COMPARATOR

Clearblue Connected Ovulation Test System

Intervention Type DEVICE

Urinary LH test to predict ovulation

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clearblue Connected Ovulation Test System

Urinary LH test to predict ovulation

Intervention Type DEVICE

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes