Connected Ovulation Test Efficacy Study

Study Overview
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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.

Official Title
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Libera Efficacy 2 Cycles at Home Study

Conditions
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Pregnancy

Intervention / Treatment
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* Device: Clearblue Connected Ovulation Test System


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COTS<br>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<br>* Urinary LH test to predict ovulation<br>|
| No Intervention: Control<br>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?
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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 |