Connected Ovulation Test Efficacy Study

Libera Efficacy 2 Cycles at Home Study

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Clearblue Connected Ovulation Test System

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Urinary LH test to predict ovulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of behaviour of women trying to conceive	Quantitative assessment in methods used to try and help with conception and intercourse patterns.	2 months
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.	2 months

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Investigators: Study Director: Sarah Johnson, Dr, SPD Development company Ltd.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2018
• Primary Completion (ACTUAL): September 19, 2018
• Study Completion (ACTUAL): September 19, 2018

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (ACTUAL): February 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-0987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No