Connected Ovulation Test Efficacy Study

Swiss Precision Diagnostics (SPD)

Status: Completed

Conditions: Pregnancy

Treatments: Device: Clearblue Connected Ovulation Test System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03424590

PROTOCOL-0987

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

COTS

Active Comparator group

Description:

Volunteers will be provided with Clearblue connected Ovulation test system to use during the study period, accortding to the instructions for use.

Treatment:

Device: Clearblue Connected Ovulation Test System

Control

No Intervention group

Description:

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.