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AzTrials

InfertilityNCT06824272

Online and Mobile Support Program and Fertility

A study testing MOBIL AND ONLINE EDUCATION in people with Infertility and Stress, run by Dokuz Eylul University.

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
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Trial summary

Our study is designed as a randomized controlled experimental study with a pre-test and post-test control group to determine the effects of online fertility preparation classes and fertility mobile application support, based on the Philosophy of Hypnofertility and Pender's Health Promotion Model, on infertile women's… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Stress
What is being tested?
MOBIL AND ONLINE EDUCATION
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
No sites listed yet
Study dates
30 Mar 2025to 1 Dec 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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Having been diagnosed with primary infertility,
  • Having been diagnosed with female, male factor and unexplained infertility,
  • Cycles where fresh embryos will be applied
  • Having In Vitro Fertilization (IVF) treatment,
  • Knowing how to read and write Turkish,
  • Being able to use a computer, internet and mobile phone
Show all 10Show fewer
  • Having a smart phone,
  • Being able to use a smart phone,
  • Having internet access,
  • Agreeing to participate in the study

Who cannot join

  • Cycles to be performed with frozen embryos
  • Having any psychiatric disorder,
  • Attending less than 80% of the trainings (not attending more than 2 classes) in this case women will be excluded from the study and in order to reach a sufficient sample, institutions will be visited again and cases that meet the sample criteria will be found. Re-randomization will be done among women who meet the criteria
  • Having any chronic disease for which they are receiving treatment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Esra ARBAG Arbag contact

+905301471889

esmus.esra@gmail.com

About this study

Official title: The Effect of a Hybrid Support Program Based on the Hypnofertility and Health Improvement Model on Infertile Women's Fertility Readiness, Self-Efficacy, Lifestyle, and Pregnancy Outcomes

Our study is designed as a randomized controlled experimental study with a pre-test and post-test control group to determine the effects of online fertility preparation classes and fertility mobile application support, based on the Philosophy of Hypnofertility and Pender's Health Promotion Model, on infertile women's fertility readiness, fertility self-efficacy, lifestyle, and pregnancy outcomes.

Read the detailed description

The research will be conducted with women who apply for infertility treatment at institutions providing such services in İzmir (İzmir Dokuz Eylul University Hospital, İzmir Ege Maternity and Women's Diseases Training and Research Hospital, İzmir Medical Park Hospital) and who agree to participate in the study and meet the sampling criteria. It is planned that the training, based on the philosophy of Hypnofertility and Pender's Health Promotion Model, will be conducted in the form of synchronous remote education through online fertility preparation classes created by the researchers. Additionally, a Fertility mobile application will be developed. In our study, training will be provided on healthy lifestyle changes for fertility, including physical activity, sleep, nutrition, and stress management. The investigators have based the content of our training on Pender's Health Promotion Model. Thus, the investigators believe that our training will help women become aware of the relationship between their health status and health behaviors, and by empowering them to change behaviors that negatively affect their fertility, the investigators will enhance health-promoting behaviors. During our training sessions, the investigators will collect data related to women's previous behaviors, personal factors (biological, psychological, and sociocultural), self-efficacy, perceived benefits, and barriers. Based on the collected data, the investigators will create a health promotion plan that takes into account the individual's past experiences, personal factors, perceived barriers, self-efficacy issues, emotional challenges, and perceived benefits of action. In the implementation phase, the investigators will ensure that individuals incorporate health-promoting behaviors into their lives and routines. In this way, the investigatorsbelieve that the training the investigators provide will contribute to making these behaviors a part of individuals' lifestyles. the investigators will use Pender's health promotion model in our training sessions as follows. For example, let's consider the topic of examining the impact of our lifestyle habits on fertility and questioning behaviors that promote fertility. The investigators will investigate the physical activity status of individuals, learning about the perceived benefits and barriers they associate with engaging in moderate physical activity, which is a healthy lifestyle behavior that enhances fertility. Based on this information, the investigators will create a program that supports individuals in incorporating moderate physical activity into their daily routines, and the investigators will even enhance this with a mobile application. Our goal here is to reduce the perceived barriers to health-promoting behaviors and increase the perceived benefits, enabling individuals to integrate health-enhancing behaviors into their lives and routines during the implementation phase. In this way, the investigators believe that by influencing the urgent needs and choices under the behavioral outcomes of Pender's model, the training the investigators provide will contribute to making these behaviors a part of individuals' lifestyles.A class will be opened when the number of women is at least 3 and at most 7. The online fertility preparation classes are aimed to be conducted synchronously during the first four weeks before the women begin IVF treatment. The synchronous part of the program is planned to be four weeks long, with two days a week and two-hour sessions (eight sessions in total). A software company will be engaged to transfer the presentations, written materials, relaxation audio recordings, and fertility massage videos into a mobile application using Android programming for the online fertility preparation classes.The organization, compliance, presentation, interaction, and navigation elements will be taken into account in the creation of the mobile application. The mobile application is planned to be designed in a simple and user-friendly organizational structure to appeal to all women as much as possible. The usability of the mobile application created on the Android platform will be tested on 5 couples who are not included in the research sample to ensure control. Couples in the intervention group will be able to download the mobile application from Playstore and App Store to their phones and start using it from the first meeting. Usernames and passwords will be created for the women in this group for their login processes. While women can use the mobile application at any time they wish, there are educational videos and audio recordings they need to follow at specific times during their treatment cycles (the first folliculometry day, the second folliculometry day, OPU day, and embryo transfer day). After women register their treatment start times in the application, they will be reminded of the educational videos they need to follow through notifications sent by the application. This application will also include a management panel where the researcher can track the women's lifestyle maps. The researcher will be able to log into this panel with a username and password to provide feedback to the women regarding their lifestyle maps (physical activity, sleep, nutrition, and stress). Additionally, the application will feature a panel where they can ask questions to the researcher and a section where they can specify the day and time they would like to receive individual counseling if they wish to do so synchronously. The mobile application will automatically send positive messages that enhance motivation, aligned with the language of hypnofertility, to women every day.

Conditions
Infertility, Stress
Being tested
MOBIL AND ONLINE EDUCATION
Keywords
Hypnofertility, Fertility Preparedness, Self-efficacy, Lifestyle, Pregnancy Outcome, Mobile Application, Online Education, infertility, pender
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOBIL AND ONLINE EDUCATIONOther

    The intervention group attended synchronous online sessions twice weekly (2 hours) for four weeks before IVF, with the mobile app available from the first session. During IVF cycles, the app provided scheduled educational content, reminders, creation of lifestyle maps, feedback,counseling scheduling, and daily motivational messages based on hypnofertility principles to enhance support.

Study groups in NCT06824272
Study groupRoleWhat they receive
InterventionExperimentalBefore the first lesson of the online fertility preparation class, the Informed Voluntary Consent Form, the Introductory Information Form, the Fertility Readiness Scale for Women Receiving Fertility Support, the Infertility Self-Efficacy Scale-Short Form (İÖYÖ-KF) and the Healthy Lifestyle Behaviors Scale for Enhancing Fertility will be administered to the women. After the online fertility preparation class is applied synchronously in groups for four weeks, the Fertility Readiness Scale, the Infertility Self-Efficacy Scale-Short Form (İÖYÖ-KF) and the Healthy Lifestyle Behaviors Scale for Enhancing Fertility will be administered to the women again in the last session. After the online fertility preparation classes, the women will start IVF treatment. At this stage, the Fertility Readiness Scale for Women Receiving Fertility Support, the Infertility Self-Efficacy Scale-Short Form and the Healthy Lifestyle Behaviors Scale for Improving Fertility will be administered to the women again.
Receives: Other: MOBIL AND ONLINE EDUCATION
ControlNo interventionThe control group will not receive any training. They will undergo routine IVF treatment. On the 2nd or 3rd day of the cycle, which is the first day of treatment, the Informed Consent Form, the Informational Brochure, the Fertility Readiness Scale for Women Receiving Fertility Support, the Infertility Self-Efficacy Scale - Short Form (ISF-SF), and the Healthy Lifestyle Behaviors Scale for Improving Fertility will be administered. One to two days before the pregnancy test, the Fertility Readiness Scale for Women Receiving Fertility Support, the Infertility Self-Efficacy Scale - Short Form (ISF-SF), and the Healthy Lifestyle Behaviors Scale for Improving Fertility will be administered again to the women. The results of the pregnancy test will be recorded, and the steps to be taken for the control group will be concluded.

What is being measured

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

  1. pregnancy outcome

    The occurrence of clinical pregnancy after treatment will be evaluated.

    Measured: 1 mounth

Secondary outcomes (1)
  1. Fertility Readiness, Self-efficacy, Lifestyle

    Fertility Readiness Scale for Women Receiving Fertility Support; A high score indicates strong fertility readiness. The minimum score that can be obtained from the scale is 23, while the maximum score is 115.

    Measured: 6 mounth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start30 Mar 2025 (estimated)
  3. Primary completion12 Aug 2025 (estimated)
  4. Study completion1 Dec 2025 (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
Model description
Our study includes an experimental group and a control group
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06824272
Sponsor's protocol ID
DEU-HF-FY-OI
Status last verified
Feb 2025
First submitted
20 Jan 2025
Last updated
13 Feb 2025
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 MOBIL AND ONLINE EDUCATION in people with Infertility and Stress, run by Dokuz Eylul 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 4 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 13 Feb 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 Esra ARBAG Arbag (+905301471889, esmus.esra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pregnancy outcome (time frame: 1 mounth). 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 13 Feb 2025.

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Online and Mobile Support Program and Fertility | AzTrials