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

Abstract

Background: 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. Materials and Methods: 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. Results: 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. Conclusions: 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.

Keywords: Clearblue Connected Ovulation Test System; conception rate; live birth rate; luteinizing hormone; ovulation testing; pregnancy.

FIG. 1.

Flow diagram of the number of volunteers participating in the study.