InfertilityınfertilitechNCT06960551
Infertility Treatment
A study testing ınfertility group in people with Infertility and Artificial Intelligence (AI), run by Inonu University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infertility, Artificial Intelligence (AI)
- What is being tested?
- ınfertility group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2025to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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),
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Digital Transformation in Infertility Treatment: Effectiveness and Future Potential of a Comprehensive Mobile Web Application (Infertilitech)
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.
Read the 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.
- Conditions
- Infertility, Artificial Intelligence (AI)
- Being tested
- ınfertility group, control group
- Keywords
- Obstetric Nursing, Primary Care Nursing, Infertility, Female, Web Browser
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ınfertility groupOther
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.
control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ınfertilitech group | Experimental | 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. Receives: Other: ınfertility group |
| control group | Other | 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infertility Adjustment Scale
The Turkish validity and reliability of the scale developed by Glover et al. was analyzed by Arslan Özkan et al. was conducted. The scale is six-point Likert-type and consists of 12 items. The scale is only administered to women. Scores that can be obtained from the scale are 12-72 ranges between the two scales. Increasing scores on the scale indicate an increase in maladjustment to loss of fertility. Cronbach's alpha coefficient was determined as 0.77
Measured: three months
Secondary outcomes (5)
Infertility Affect Scale
The scale developed by Akyüz et al. (2008) assesses women's level of being psychologically affected by infertility. determines. The scale is four-point Likert-type and consists of 21 items. There are 16 positive and 5 negative items in the scale. The items in the scale Items 3, 10, 13, 14 and 21 are expressed negatively and these items are reverse coded. Scores that can be obtained from the scale range between 21-84 varies. The higher the scores obtained from the scale, the higher the level of psychological impact of infertility. Cronbach alpha coefficient was determined as 0.93
Measured: three months
Participant Information Form
The participant information form developed by the researchers in line with the literature consists of two parts. Form one age, educational status, occupation, income, duration of marriage, duration of infertility, and knowledge of the cause of infertility, cause of infertility, diagnosed infertility, frequency of past infertility treatment, name of past infertility treatment, current the infertility treatment received, the planned stage of infertility treatment, the medication currently being taken, any incorrect or faulty medication used during treatment practice status, use of traditional methods for infertility treatment, traditional methods used, 18 questions including traditional methods used takes
Measured: three months
Infertility Self-Efficacy Scale-Short Form
The Turkish validity and reliability of the scale developed by Cousineau et al. Özkan et al. (2012). The scale is applied only to women. The scale is four-point Likert-type and consists of 8 items. In the scale All items are positive and the scores that can be obtained from the scale vary between 8-32. As the scores obtained from the scale increase, individuals' self-efficacy perception increased. Croncah alpha coefficient of the scale was determined as 0.78
Measured: three months
State-Trait Anxiety Inventory
The Turkish validity and reliability of the inventory developed by Spielberger et al. Compte (1983). The four-point Likert-type inventory, which is suitable for both women and men, consists of 40 items. It consists of two subscales, state and trait anxiety. The State Anxiety Scale assesses how the individual feels at a certain moment and under certain conditions. It evaluates their feelings about the situation they are in by describing how they feel. The Trait Anxiety Scale assesses how the individual usually feeling of being a victim. Both scales consisted of twenty items each. The total score value obtained from the scale ranges between 20 and 80. It was determined that as the score increased, the level of anxiety increased and as the score decreased, the level of anxiety decreased.
Measured: three months
User Version of the Mobile Application Rating Scale
Calik et al. (2022) conducted the Turkish validity and reliability study of the scale developed by Calik et al. Quality of health practices uMARS, developed to assess quality, consists of five subscales, a five-point Likert-type scale and 20 items. Four subscales are objective and quality rating. These are participation (5 items), functionality (4 items), aesthetics (3 items) and knowledge (4 items). One subscale is evaluated subjectively (4 items). The perceived impact subscale has 6 items and evaluates the impact of the perception of the application by the user. A minimum of 20 and a maximum of 100 points are obtained from the scale. The higher the score, the higher the validity of the mobile application. The project, the application password is available for women as well as their spouses. will be given. In the project, the UMARS form will be used in the post-test to assess the spouses' satisfaction with the mobile application/WhatsApp. will be asked to fill in the form.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start20 Jun 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The project was planned as an experimental research with pretest-posttest experimental and control groups.
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simge Ozturk, Inonu University
- Investigators
- Simge Öztürk, Ph.D, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960551
- Sponsor's protocol ID
- Inonu5
- Acronym
- ınfertilitech
- Status last verified
- May 2025
- First submitted
- 3 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Transformation in Infertility Treatment: Effectiveness and Future Potential of a Comprehensive Mobile Web Application (Infertilitech)
- ClinicalTrials.gov ID
- NCT06960551
- Acronym / sponsor ID
- ınfertilitech / Inonu5
- Conditions
- Infertility, Artificial Intelligence (AI)
- Keywords
- Obstetric Nursing, Primary Care Nursing, Infertility, Female, Web Browser
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The project was planned as an experimental research with pretest-posttest experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| ınfertilitech group | Experimental | Other: ınfertility groupBefore 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. |
| control group | Other | Other: control groupWomen 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ınfertility groupBefore 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. | Other | ınfertilitech group |
| control groupWomen 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. | Other | control group |
Primary outcome
Infertility Adjustment Scale
Time frame: three months
The Turkish validity and reliability of the scale developed by Glover et al. was analyzed by Arslan Özkan et al. was conducted. The scale is six-point Likert-type and consists of 12 items. The scale is only administered to women. Scores that can be obtained from the scale are 12-72 ranges between the two scales. Increasing scores on the scale indicate an increase in maladjustment to loss of fertility. Cronbach's alpha coefficient was determined as 0.77
5 secondary outcomes
Infertility Affect Scale
Time frame: three months
Participant Information Form
Time frame: three months
Infertility Self-Efficacy Scale-Short Form
Time frame: three months
State-Trait Anxiety Inventory
Time frame: three months
User Version of the Mobile Application Rating Scale
Time frame: three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simge Öztürk, Ph.D principal investigator
Inonu University
Questions about this trial
What is this clinical trial studying?
A study testing ınfertility group in people with Infertility and Artificial Intelligence (AI), run by Inonu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simge Öztürk, Ph.D (+905398751788, simgeozturk2123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infertility Adjustment Scale (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025; AzTrials last refreshed its copy on 28 Oct 2026.