Connected Ovulation Test Efficacy Study

Pregnancy Clinical Trial

Official title:

Libera Efficacy 2 Cycles at Home Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424590
• Other study ID #: PROTOCOL-0987
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: September 19, 2018

Study information

• Verified date: July 2018
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 19, 2018
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Clearblue Connected Ovulation Test System
Urinary LH test to predict ovulation

Locations

Country	Name	City	State
United Kingdom	SPD Development Company Ltd	Bedford	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of behaviour of women trying to conceive	Quantitative assessment in methods used to try and help with conception and intercourse patterns.	2 months
Secondary	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