Increased Chance of Live Birth Following Use of Connected Ovulation Test System: Outcome Results from a Randomized...

Natural conception requires intercourse to occur during the fertile window of a woman's menstrual cycle. This follow-up study of a randomized controlled trial aimed to determine whether the use of a urine ovulation test system, which tracks elevations in both luteinizing hormone and an estradiol metabolite, increases the likelihood of live births in women trying to conceive. In the home-based trial, 844 women aged 18-40 years who were attempting to conceive were randomized 1:1 into the test or control arms. Volunteers participated for up to two full cycles and conducted digital pregnancy tests, collected urine samples, and kept a menstrual diary to determine pregnancy status. In this follow-up, all pregnant volunteers were asked to complete a form on final pregnancy outcome. Overall, 247 (29.3%) of the 844 volunteers reported a pregnancy; final outcome data were available for 198 pregnancies. For cycle one, the live birth rate was 16.4% for the test group and 8.5% for the control group (odds ratio: 2.12; 95% confidence interval [CI]: 1.34-3.35; p = 0.001). For cycles one and two combined, the live birth rate was 24.5% and 17.5% for the test and control groups, respectively (odds ratio: 1.53; 95% CI: 1.07-2.19; p = 0.023). The proportion of miscarriages was not significantly different between both groups and 78% of pregnancies resulted in a live birth. The increased conception rate observed following the use of the Clearblue Connected Ovulation Test System was found to translate into an increased live birth rate. Clinical Trial Registration number: NCT03424590.