Status:
COMPLETED
Connected Ovulation Test Efficacy Study
Lead Sponsor:
SPD Development Company Limited
Conditions:
Pregnancy
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2018
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03424590
Start Date
January 29 2018
End Date
September 19 2018
Last Update
October 19 2018
Active Locations (1)
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1
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom, MK44 3UP