AzTrials
AzTrials

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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
What is being tested?
Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education Booklet and Digital Healthy Lifestyle Education Booklet
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.

Duygu DOKUMACI, MSc, PhD Candidate contact

+905076503518

duygu.dokumaci@gmail.com

Dilek COSKUNER POTUR, PhD contact

dilekcp@yahoo.com

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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07460661
Study groupRoleWhat they receive
Gamified Healthy Lifestyle Education + Digital Healthy Lifestyle Education BookletExperimentalGamified 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 BookletExperimentalA 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
ControlNo interventionNo Intervention Standard ART Clinic Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted10 Mar 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in