Pregnancy
Conditions
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 of female volunteers seeking to get pregnant who use COTS in comparison to those not using an ovulation product to assist with conception.
Interventions
Urinary LH test to predict ovulation
Sponsors
SPD Development Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention. | 2 months | The difference in pregnancy rates between volunteers trying to conceive in the home setting using (i) COTS (ii) no intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of behaviour of women trying to conceive | 2 months | Quantitative assessment in methods used to try and help with conception and intercourse patterns. |
| Evaluation of women's experience of trying to conceive using COTS compared to not using ovulation tests | 2 months | Qualitative interview responses regarding usage and experience of COTS or other methods whilst trying to conceive. |
Countries
United Kingdom
Outcome results
None listed