Clinical trial NCT06960551: Infertility Treatment
Official title: Digital Transformation in Infertility Treatment: Effectiveness and Future Potential of a Comprehensive Mobile Web Application (Infertilitech)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility
Artificial Intelligence (AI)
Keywords: Obstetric Nursing
Primary Care Nursing
Infertility, Female
Web Browser
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The project was planned as an experimental research with pretest-posttest experimental and control groups.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infertility Adjustment Scale
timeFrame: three months
Secondary outcomes:
measure: Infertility Affect Scale
timeFrame: three months
measure: Participant Information Form
timeFrame: three months
measure: Infertility Self-Efficacy Scale-Short Form
timeFrame: three months
measure: State-Trait Anxiety Inventory
timeFrame: three months
measure: User Version of the Mobile Application Rating Scale
timeFrame: three months
Other outcomes:
Locations:
Study officials:
affiliation: Inonu University
name: Simge Öztürk, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: