Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-29 @ 11:35 PM
Study NCT ID:
NCT06960551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2025-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infertility Treatment
Sponsor:
Inonu University
Organization:
Study Overview
Official Title:
Digital Transformation in Infertility Treatment: Effectiveness and Future Potential of a Comprehensive Mobile Web Application (Infertilitech)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ınfertilitech
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: