Connected Ovulation Test Efficacy Study

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