Hun Eng

Dear Visitor!

We would like to introduce you our current study, which is part of the European collaboration of the FEMaLe Project (Finding Endometriosis using Machine Learning).

In the name of the FEMaLe Project you could see the word „endometriosis”, although you may not be affected by the disease. (If you have not heard of endometriosis, we recommend the Lucy app's Knowledge Base, which you can access by downloading the app.)

The aim of our study is to find out more about patients living with endometriosis. To achieve this, we also need to ask healthy women who do not have endometriosis about the characteristics of their menstrual cycle, quality of life and lifestyle. Therefore, we expect all female respondents between 18 and 45 years of age to participate.

In this survey, we would track your women's health indicators on a monthly basis for a year, by asking you to answer just 40-45 questions at the first time, and 23-28 questions later. The questions can be answered in a short time frame, there are no right or wrong answers, so we would encourage all participants to answer our questions honestly, according to their current menstruation cycle.

The survey uses data from 12 time points to track the health of participants, the stability, or changes in the health status. These values will allow us to identify different patterns and, based on these patterns, to further improve the quality of gynaecological care according to the health conditions and needs of women today. As part of this, we will also start by looking at patterns associated with endometriosis to help early detection and early diagnosis of endometriosis.

How to apply for the study

The first step in indicating your willingness to participate in the study is to download the Lucy app to your Android or iOS mobile phone. The usage the mobile app itself and the study participation is anonymous. Each month, the questionnaire for the following month will be available on the Lucy interface. It is important to note that a minimum of 30 days will elapse between each questionnaire completion, so if a participant completed the first questionnaire on 22 January 2022, the next questionnaire will be available from 22 February 2022.

Process of the investigation and data management

Research questionnaires are published every month in the Lucy app. Both the Lucy app and our research are anonymous, so neither the survey managers, nor our development engineers, nor even our data analysts will know which data came from whom.

We will reach participants with 12 surveys (25-45 questions per pack), twice a month. On the first occasion we will indicate that the questionnaire interface for the new month has been opened, and on the second occasion we will send a reminder to complete it if it was not convenient for the participant at the first time.

The questions include some questions that some people consider too personal to answer. If you do not wish to answer these questions, please do not feel uncomfortable. Your answers will be encrypted in a central database, accessible only to the research manager and our data processing staff. Due to anonymity, your personal answers will not be identifiable when the results of the survey will be published. You may stop or refuse to participate in the survey or to refuse to participate at any time without giving any reason.

There will be no (medical) intervention in the study; there will be no extra costs for you to participate in the research and no financial benefit for the participation.

Benefits of participating in the study

Each month, the questionnaires provide an opportunity to reflect on your own women's health, and the answers allow each participant to monitor its stability or change. Month by month, our knowledge is growing, and our research team is using it into the field of care.

Further, each month, we will raise and present a topic related to health promotion, based on recent research findings, to help you explore lifestyle options and consciously maintain women's health.

Expected results of the study

The study is expected to run for 1-1.5 years until the number of participants needed for the study is reached. The data will then be aggregated and sent to our consortium partners within the FEMaLe Project, who will start analyzing the data once the international database is available. Our aim is to write publications and conference presentations from our results, which will be made available to interested parties and participants as well.

No final medical report or laboratory report will be produced on the results of the study. We are not able to provide feedback on individual results of participants, but we can provide feedback on aggregate results.

Technical details of the study

Name of study not involving an intervention: FEMaLe – Finding Endometriosis using Machine Learning.

The investigator-in-charge: Dr. Bokor Attila PhD, egyetemi docens (Semmelweis Egyetem Szülészeti és Nőgyógyászati Klinika Baross utcai részleg, 1082 Budapest, Baross utca 27.)

Registration number of the study:

Contact

Questions about the app and how to use it can be asked here lucyappinfo@gmail.com ; while for questions and queries about the study, please contact XY, Research Coordinator of the FEMaLe Project Hungarian team (marki.gabriella@gmail.com).

The investigator-in-charge thanks you in advance for your cooperation,
Dr. Bokor Attila, MD, PhD.
egyetemi docens, SE ÁOK Szülészeti és Nőgyógyászati Klinika

DECLARATION OF CONSENT

By starting to fill in the questionnaire in the Lucy app, I declare that I voluntarily participate in the research led by Dr. Attila Bokor, PhD., Assistant Professor (Department of Obstetrics and Gynaecology, SE ÁOK) and supported by the Finding Endometriosis using Machine Learning (FEMaLe) Project. I was informed about the nature of the study and the anonymous method of the study before filling in the questionnaire.

●

●

●

●