Infertility in Women Undergoing Assisted Reproductive TreatmentNCT07460661
Gamified Healthy Lifestyle Training in Women Undergoing Assisted Reproductive Treatment
A study testing Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education Booklet and Digital Healthy Lifestyle Education Booklet in people with Infertility in Women Undergoing Assisted Reproductive Treatment and Infertility, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Objective: A prospective randomized controlled trial with a pretest-posttest design was planned to evaluate the effects of a gamified healthy lifestyle behaviors training intervention using the D6 model, to be administered to women undergoing assisted reproductive treatment (ART), on healthy lifestyle behaviors and… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility in Women Undergoing Assisted Reproductive Treatment, Infertility, Assisted Reproductive Technology
- What is being tested?
- Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education Booklet and Digital Healthy Lifestyle Education Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Mar 2027
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-49 years
- Diagnosed with primary infertility
- Currently undergoing assisted reproductive treatment (IUI, IVF, or ICSI)
- Able to read, understand, and communicate in Turkish
- Have access to a digital device (mobile phone, tablet, or computer) and internet connection
- Provide voluntary written informed consent
Who cannot join
- Diagnosed psychiatric disorder that may interfere with participation
- Presence of a severe medical condition (e.g., active cancer or other serious systemic disease) that may affect treatment outcomes
- Medical complications requiring hospitalization during the study period
- Communication barriers preventing completion of study procedures
- Withdrawal of consent at any time during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dilek COSKUNER POTUR, PhD contact
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital
Istanbul, Uskudar, 34668
Belgin Devranoglu, PhD, +902163910680, belgin.devranoglu@sbu.edu.tr
About this study
Official title: The Effect of Gamified Healthy Lifestyle Behavior Training on Healthy Lifestyle and Self-Efficacy in Women Undergoing Assisted Reproductive Treatment
Objective: A prospective randomized controlled trial with a pretest-posttest design was planned to evaluate the effects of a gamified healthy lifestyle behaviors training intervention using the D6 model, to be administered to women undergoing assisted reproductive treatment (ART), on healthy lifestyle behaviors and infertility self-efficacy.
Aim: Reproductive health and Assisted Reproductive Technologies (ART) have undergone rapid technological and clinical development in recent years, offering a variety of treatment options to couples struggling with infertility. Methods such as Intrauterine Insemination (IUI), In Vitro Fertilization (IVF), and Intracytoplasmic Sperm Injection (ICSI) are the most common practices aimed at increasing pregnancy rates. However, these treatments are complex processes affected by high stress levels, emotional burden, and lifestyle factors. Strengthening individuals' sense of self-efficacy strengthens their motivation to adapt to treatment and achieve health-related goals. In this intense and complex treatment process, it is essential to strengthen the self-efficacy perceptions of infertile couples, as this can enhance their motivation to achieve health-related goals by improving their adaptation to the treatment process. Although the literature reveals findings indicating that the development of healthy lifestyle behaviors positively influences the treatment outcomes of individuals undergoing infertility treatment, it is an undeniable fact that developing and sustaining such behaviors is often challenging-even for healthy individuals. For those experiencing infertility, which represents a complex life crisis both psychologically and physiologically, this process can become even more difficult. In this context, gamification is intended to be utilized as an innovative approach by integrating it into the process of promoting healthy lifestyle behaviors among infertile women.
Read more
Method: This study will be a prospective randomized controlled trial with a pretest-posttest model. The study population will consist of women undergoing assisted reproductive treatment who presented to the In Vitro Fertilization Unit in the Infertility and Reproductive Endocrinology Department at Istanbul University, Istanbul Faculty of Medicine Service Building, between October 2025 and October 2026. The sample will consist of 105 infertile women who met the study criteria based on a power analysis and agreed to participate in the study. After obtaining informed consent from infertile women who meet the study criteria and agree to participate, the women will be randomly assigned to three groups based on age, type of ART (IUI, IVF, ICSI), and number of treatments to ensure equality between the groups. These groups will be divided into three groups: a group receiving gamified healthy lifestyle behaviors education and a booklet during the ART process, a group receiving only the booklet, and a group receiving standard ART clinic training. All study groups will complete an Introductory Information Form, the Healthy Lifestyle Behavior Follow-up Form for Infertile Women, the Healthy Lifestyle Behavior Scale II (HLBS II), and the Infertility Self-Efficacy Scale Short Form (SES). One group will receive the gamified healthy lifestyle behaviors education program and a booklet, while the second group will receive the healthy lifestyle behaviors education booklet. The third group will receive standard ART clinic training. Post-tests (Healthy Lifestyle Behaviors for Infertile Women Follow-up Form, Healthy Lifestyle Behaviors Scale II, Infertility Self-Efficacy Scale Short Form) and "Gamified Healthy Lifestyle Behaviors Training Program Evaluation Form" was given to the group receiving gamified healthy lifestyle behaviors training will be administered to all groups at the end of Month 1. Repeat tests (Healthy Lifestyle Behaviors for Infertile Women Follow-up Form, Healthy Lifestyle Behaviors Scale II, Infertility Self-Efficacy Scale Short Form, and Gamified Healthy Lifestyle Behaviors Education Program Evaluation Form) will be administered at Month 3.
As part of the study, the effects of gamified healthy lifestyle behaviors and self-efficacy on the healthy lifestyle behaviors and self-efficacy of infertile women who received gamified healthy lifestyle behaviors education and an educational booklet during the ART process will be compared with those of infertile women who received only the educational booklet, compared to those who received standard ART clinic training. This will scientifically demonstrate the contribution of the gamification approach to the behavioral change processes of infertile women.
- Conditions
- Infertility in Women Undergoing Assisted Reproductive Treatment, Infertility, Assisted Reproductive Technology, Health Lifestyle Behaviors, Self-Efficacy
- Being tested
- Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education Booklet, Digital Healthy Lifestyle Education Booklet
- Keywords
- Assisted Reproductive Treatment, Infertility, Healthy Lifestyle, Gamification, Self-Efficacy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education BookletBehavioural
A structured, theory-based gamified healthy lifestyle education program developed in accordance with the D6 gamification model. The program is delivered via a digital platform and includes modules focusing on nutrition, physical activity, stress management, and social support. Gamification elements such as points, badges integrated to enhance motivation and participant engagement. In addition to gamified healthy lifestyle behavior training, a digital training booklet is also provided. The intervention is implemented alongside routine clinical care.
Digital Healthy Lifestyle Education BookletBehavioural
An evidence-based, digitally delivered healthy lifestyle education booklet. The booklet contains structured information on nutrition, physical activity, stress management, health responsibility, and social support for women undergoing assisted reproductive treatment. Participants receive this booklet in addition to their routine clinical training.
| Study group | Role | What they receive |
|---|---|---|
| Gamified Healthy Lifestyle Education + Digital Healthy Lifestyle Education Booklet | Experimental | Gamified Healthy Lifestyle Education:
A structured gamified healthy lifestyle behaviors education program based on the D6 gamification model. The intervention includes digital interactive modules covering nutrition, physical activity, stress management, health responsibility, and social support, delivered via an online platform during the assisted reproductive treatment process. Receives: Behavioral: Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education Booklet |
| Digital Healthy Lifestyle Education Booklet | Experimental | A digital healthy lifestyle education booklet developed based on current evidence, including information on nutrition, physical activity, stress management for women undergoing assisted reproductive treatment. Receives: Behavioral: Digital Healthy Lifestyle Education Booklet |
| Control | No intervention | No Intervention Standard ART Clinic Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Lifestyle Behaviors
Change in healthy lifestyle behaviors measured using the Healthy Lifestyle Behaviors Scale II (HLBS-II). The scale assesses health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. Higher scores indicate better healthy lifestyle behaviors.The scale has no cut-off value. Total scores range from 52 to 208, with higher scores indicating better outcomes.
Measured: At baseline and at 4 and 12 weeks
Secondary outcomes (1)
Infertility Self-Efficacy
Change in infertility self-efficacy measured using the Infertility Self-Efficacy Scale Short Form. Total scores range from 8 to 32; higher scores indicate greater perceived ability to cope with infertility-related challenges and treatment processes.
Measured: At baseline and at 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility in Women Undergoing Assisted Reproductive TreatmentStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Potur, Marmara University
- Investigators
- Dilek COSKUNER POTUR, PhD, Principal investigator, Marmara UniversityDUYGU DOKUMACI, MSc, PhD Candidate, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460661
- Sponsor's protocol ID
- Doktora1001
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 10 Mar 2026
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gamified Healthy Lifestyle Behavior Training on Healthy Lifestyle and Self-Efficacy in Women Undergoing Assisted Reproductive Treatment
- ClinicalTrials.gov ID
- NCT07460661
- Acronym / sponsor ID
- Doktora1001
- Conditions
- Infertility in Women Undergoing Assisted Reproductive Treatment, Infertility, Assisted Reproductive Technology, Health Lifestyle Behaviors, Self-Efficacy
- Keywords
- Assisted Reproductive Treatment, Infertility, Healthy Lifestyle, Gamification, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
Objective: A prospective randomized controlled trial with a pretest-posttest design was planned to evaluate the effects of a gamified healthy lifestyle behaviors training intervention using the D6 model, to be administered to women undergoing assisted reproductive treatment (ART), on healthy lifestyle behaviors and infertility self-efficacy.
Aim: Reproductive health and Assisted Reproductive Technologies (ART) have undergone rapid technological and clinical development in recent years, offering a variety of treatment options to couples struggling with infertility. Methods such as Intrauterine Insemination (IUI), In Vitro Fertilization (IVF), and Intracytoplasmic Sperm Injection (ICSI) are the most common practices aimed at increasing pregnancy rates. However, these treatments are complex processes affected by high stress levels, emotional burden, and lifestyle factors. Strengthening individuals' sense of self-efficacy strengthens their motivation to adapt to treatment and achieve health-related goals. In this intense and complex treatment process, it is essential to strengthen the self-efficacy perceptions of infertile couples, as this can enhance their motivation to achieve health-related goals by improving their adaptation to the treatment process. Although the literature reveals findings indicating that the development of healthy lifestyle behaviors positively influences the treatment outcomes of individuals undergoing infertility treatment, it is an undeniable fact that developing and sustaining such behaviors is often challenging-even for healthy individuals. For those experiencing infertility, which represents a complex life crisis both psychologically and physiologically, this process can become even more difficult. In this context, gamification is intended to be utilized as an innovative approach by integrating it into the process of promoting healthy lifestyle behaviors among infertile women.
Method: This study will be a prospective randomized controlled trial with a pretest-posttest model. The study population will consist of women undergoing assisted reproductive treatment who presented to the In Vitro Fertilization Unit in the Infertility and Reproductive Endocrinology Department at Istanbul University, Istanbul Faculty of Medicine Service Building, between October 2025 and October 2026. The sample will consist of 105 infertile women who met the study criteria based on a power analysis and agreed to participate in the study. After obtaining informed consent from infertile women who meet the study criteria and agree to participate, the women will be randomly assigned to three groups based on age, type of ART (IUI, IVF, ICSI), and number of treatments to ensure equality between the groups. These groups will be divided into three groups: a group receiving gamified healthy lifestyle behaviors education and a booklet during the ART process, a group receiving only the booklet, and a group receiving standard ART clinic training. All study groups will complete an Introductory Information Form, the Healthy Lifestyle Behavior Follow-up Form for Infertile Women, the Healthy Lifestyle Behavior Scale II (HLBS II), and the Infertility Self-Efficacy Scale Short Form (SES). One group will receive the gamified healthy lifestyle behaviors education program and a booklet, while the second group will receive the healthy lifestyle behaviors education booklet. The third group will receive standard ART clinic training. Post-tests (Healthy Lifestyle Behaviors for Infertile Women Follow-up Form, Healthy Lifestyle Behaviors Scale II, Infertility Self-Efficacy Scale Short Form) and "Gamified Healthy Lifestyle Behaviors Training Program Evaluation Form" was given to the group receiving gamified healthy lifestyle behaviors training will be administered to all groups at the end of Month 1. Repeat tests (Healthy Lifestyle Behaviors for Infertile Women Follow-up Form, Healthy Lifestyle Behaviors Scale II, Infertility Self-Efficacy Scale Short Form, and Gamified Healthy Lifestyle Behaviors Education Program Evaluation Form) will be administered at Month 3.
As part of the study, the effects of gamified healthy lifestyle behaviors and self-efficacy on the healthy lifestyle behaviors and self-efficacy of infertile women who received gamified healthy lifestyle behaviors education and an educational booklet during the ART process will be compared with those of infertile women who received only the educational booklet, compared to those who received standard ART clinic training. This will scientifically demonstrate the contribution of the gamification approach to the behavioral change processes of infertile women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gamified Healthy Lifestyle Education + Digital Healthy Lifestyle Education Booklet | Experimental | Behavioral: Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education BookletGamified Healthy Lifestyle Education: A structured gamified healthy lifestyle behaviors education program based on the D6 gamification model. The intervention includes digital interactive modules covering nutrition, physical activity, stress management, health responsibility, and social support, delivered via an online platform during the assisted reproductive treatment process. |
| Digital Healthy Lifestyle Education Booklet | Experimental | Behavioral: Digital Healthy Lifestyle Education BookletA digital healthy lifestyle education booklet developed based on current evidence, including information on nutrition, physical activity, stress management for women undergoing assisted reproductive treatment. |
| Control | No intervention | –No Intervention Standard ART Clinic Education |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18-49 years
- Diagnosed with primary infertility
- Currently undergoing assisted reproductive treatment (IUI, IVF, or ICSI)
- Able to read, understand, and communicate in Turkish
- Have access to a digital device (mobile phone, tablet, or computer) and internet connection
Key exclusion criteria (5 listed)
- Diagnosed psychiatric disorder that may interfere with participation
- Presence of a severe medical condition (e.g., active cancer or other serious systemic disease) that may affect treatment outcomes
- Medical complications requiring hospitalization during the study period
- Communication barriers preventing completion of study procedures
- Withdrawal of consent at any time during the study
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 |
|---|---|---|
| Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education BookletA structured, theory-based gamified healthy lifestyle education program developed in accordance with the D6 gamification model. The program is delivered via a digital platform and includes modules focusing on nutrition, physical activity, stress management, and social support. Gamification elements such as points, badges integrated to enhance motivation and participant engagement. In addition to gamified healthy lifestyle behavior training, a digital training booklet is also provided. The intervention is implemented alongside routine clinical care. | Behavioural | Gamified Healthy Lifestyle Education + Digital Healthy Lifestyle Education Booklet |
| Digital Healthy Lifestyle Education BookletAn evidence-based, digitally delivered healthy lifestyle education booklet. The booklet contains structured information on nutrition, physical activity, stress management, health responsibility, and social support for women undergoing assisted reproductive treatment. Participants receive this booklet in addition to their routine clinical training. | Behavioural | Digital Healthy Lifestyle Education Booklet |
Primary outcome
Healthy Lifestyle Behaviors
Time frame: At baseline and at 4 and 12 weeks
Change in healthy lifestyle behaviors measured using the Healthy Lifestyle Behaviors Scale II (HLBS-II). The scale assesses health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. Higher scores indicate better healthy lifestyle behaviors.The scale has no cut-off value. Total scores range from 52 to 208, with higher scores indicating better outcomes.
1 secondary outcome
Infertility Self-Efficacy
Time frame: At baseline and at 4 and 12 weeks
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 10 Mar 2026.
- 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.
Dilek COSKUNER POTUR, PhD contact
Dilek COSKUNER POTUR, PhD principal investigator
Marmara University
DUYGU DOKUMACI, MSc, PhD Candidate study chair
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education Booklet and Digital Healthy Lifestyle Education Booklet in people with Infertility in Women Undergoing Assisted Reproductive Treatment and Infertility, run by Marmara University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Duygu DOKUMACI, MSc, PhD Candidate (+905076503518, duygu.dokumaci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Lifestyle Behaviors (time frame: At baseline and at 4 and 12 weeks). 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 10 Mar 2026.