Grada van den Dool, Gonnie van Osta and Maarten Wiegerinck
Correspondence Address :
Received on: 29 March 2021, Accepted on: 12 April 2021, Published on: 14 April 2021
Citation: Grada van den Dool, Gonnie van Osta, Maarten Wiegerinck (2021) The FERTI•LILY Conception Cup Increases the Chance of Conceiving in Comparison with Expected Pregnancy Rates: A Prospective Observational Study
Copyright: 2021 Maarten Wiegerinck, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: With the average age of first-time mothers increasing over the last decades in the Western countries, difficulties to conceive naturally are rising in parallel.
The FERTI·LILY Conception Cup (FCC) is a medical device designed to stimulate natural conception. The aim of the current study was to evaluate the safety, efficacy, and user feasibility of the FCC.
Material and methods: 85 female volunteers trying to conceive entered the prospective, 1-arm, open label, non-randomized, observational study and were followed-up for maximally 3 months. The pregnancy rate observed in the study was compared to the pregnancy expectation based on 2 prognostic models to determine the device’s efficacy. Through questionnaires, information about safety, pregnancy, and user feasibility was collected.
Results: Of the 85 study participants, 65 used the product as instructed throughout the study. No Adverse Events (AEs) were reported. 23 participants conceived during the study, resulting in an overall pregnancy rate of 35.4% in the population that completed the study according to protocol, in contrast to the predicted rate of 23.9% (p < 0.05). Assessment of an infertile subpopulation resulted in a pregnancy rate of 30.3% in comparison with the predicted rate of 9.4% (p < 0.05). Study participants agreed that the FCC was comfortable and easy to use.
Conclusions: The FCC is a safe, comfortable, and easy to use medical device that significantly increases pregnancy rates, even in couples with fertility issues. A larger study is planned to provide additional data on pregnancy rates associated with the use of the FCC.
Keywords: Efficacy; FERTI·LILY Conception Cup; Medical device; Post-market evaluation; Pregnancy outcome; Safety