Clinical trial NCT03424590: Connected Ovulation Test Efficacy Study
Official title: Libera Efficacy 2 Cycles at Home Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention.
timeFrame: 2 months
Secondary outcomes:
measure: Assessment of behaviour of women trying to conceive
timeFrame: 2 months
measure: Evaluation of women's experience of trying to conceive using COTS compared to not using ovulation tests
timeFrame: 2 months
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development Company Ltd.
name: Sarah Johnson, Dr
role: STUDY_DIRECTOR
References:
citation: Johnson S, Bond S, Grace B, Marriott L. Increased Chance of Live Birth Following Use of Connected Ovulation Test System: Outcome Results from a Randomized Controlled Trial. Womens Health Rep (New Rochelle). 2022 Jan 31;3(1):60-66. doi: 10.1089/whr.2021.0102. eCollection 2022.