Infertility Treatment (ınfertilitech)

Inonu University

Status: Begins enrollment this month

Conditions: Infertility; Artificial Intelligence (AI)

Treatments: Other: ınfertility group; Other: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06960551

Inonu5

Details and patient eligibility

About

The primary objective of this project is to increase the treatment compliance and success of infertile couples based on the Knowledge-Motivation-Behavioral Skills model.

To develop a mobile web application and evaluate its effectiveness with scientific methods.

The secondary aim was to evaluate the effect of using a mobile application on Infertility Affect Status, Self-Efficacy, Infertility Adjustment and State-Trait Anxiety.

effect of the impact of the study.

Full description

Infertility is a serious health problem affecting 8-12% of couples worldwide. This situation causes couples to face significant biopsychosocial and economic difficulties. Infertility process needs a multidisciplinary approach due to the diversity of etiological factors and complexity of treatment options. Especially in patriarchal societies, the problem of infertility may lead to negativities such as divorce, polygamy and social exclusion. In Turkey, the cultural importance of having children increases the psychological pressure on infertile couples. The coverage of infertility treatment by public institutions is limited. Therefore, couples often have to turn to the private sector and face high costs. Currently, infertile couples' sources of access to information are largely limited to the web pages of private infertility centres. In this context, the development of an evidence-based, reliable and free mobile web application for infertile couples emerges as a critical need. The main aim of this project is to develop a mobile web application to increase the treatment compliance and success of infertile couples and to evaluate its effectiveness with scientific methods. Original contributions are as follows:

• Creating a national comprehensive and culturally sensitive mobile web application different from the existing web pages on infertility. Regular updating and sharing of evidence-based medical and supportive treatment methods.
• Providing a structure that includes women as well as their husbands and family members in the process.

Inclusion of non-pharmacological methods (mindfulness etc.) in addition to medical treatments.

• Providing personalised information with the Ask Me module supported by artificial intelligence.
• R&D and scientific testing of the application with a randomised controlled trial.

In the second phase of the project, a randomised controlled study will be conducted with 74 individuals in the experimental group and 74 individuals in the control group who are treated in two infertility centres and who are determined by G-power. In the project, individuals in the experimental group will be asked to use the application for at least three months. Data will be collected using the Participant Information Form, measurement tools for infertility treatment compliance and success, and Mobile Application Evaluation Form. The user experience, interaction level and the effects of the application on increasing adherence to treatment will also be analysed. With the successful completion of the project, it is envisaged that a national mobile application will be created, the application will be translated into different languages to expand its usage area and economic sustainability will be ensured. In addition, it is planned to contribute to health policies in line with the scientific data obtained, to increase the effectiveness of digital health solutions for infertility and to facilitate access to health services.

Enrollment: 148 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

for women;

• To be between the ages of 18-45,
• Being diagnosed with primary infertility,
• To be able to read, write and understand Turkish,
• Not having a disability to use a smartphone,
• Being at the stage of agreeing to start infertility treatment (initial period of treatment),
• Using the mobile app at least 4 times a week for 15 minutes each for 3 months for partner
• Volunteer to participate in the project,
• Not having a disability to use a smartphone,
• Using the mobile app at least 1 time/15 minutes per week for 3 months

Exclusion criteria

for women

• Incomplete answers to forms,
• Not using the mobile app at all for a week,
• Wanting to leave the study,
• Voluntary discontinuation of infertility treatment for partner
• Incomplete completion of the forms (uMARS and State-Trait Anxiety Inventory),
• Not using the mobile app at all for two weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

ınfertilitech group

Experimental group

Description:

Before starting the project, the couples in the experimental group will be informed about the mobile application. The women will use the mobile application weekly for 3 months. 4 times for at least 15 minutes each. To create motivation for use, women in the experimental group will be asked to motivational notification will be sent via the mobile application.

Treatment:

Other: ınfertility group

control group

Other group

Description:

Women in the control group will not receive any intervention. After collecting the post-test data in the project, the principle of benefit and equality Taking this into account, women and their husbands participating in the control group will be given the opportunity to use the mobile application free of charge for three months.

Treatment:

Other: control group