Online and Mobile Support Program and Fertility

February 12, 2025 updated by: ESRA ARBAG, Dokuz Eylul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
    • Having a smart phone,
    • Being able to use a smart phone,
    • Having internet access,
    • Agreeing to participate in the study

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Before 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.
Other: MOBIL AND ONLINE EDUCATION
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.
No Intervention: Control
The 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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pregnancy outcome
Time Frame: 1 mounth
The occurrence of clinical pregnancy after treatment will be evaluated.
1 mounth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fertility Readiness, Self-efficacy, Lifestyle
Time Frame: 6 mounth
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.
6 mounth

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fertility Self Eficacy
Time Frame: 6 mounth
The Infertility Self-Efficacy Scale - Short Form (ISSS-SF) scores range from 8 to 32. As the score increases, the perception of self-efficacy is considered to be higher. All statements in the scale are positively worded, and there is no cutoff point for the scale.
6 mounth
Healthy Lifestyle Behaviors
Time Frame: 6 mounth
The 46-item Scale of Healthy Lifestyle Behaviors in Fertility Development is scored on a 5-point Likert scale, with a minimum score of 46 and a maximum score of 230. An increase in the scale score indicates a higher intensity of healthy lifestyle behaviors among individuals.
6 mounth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: DEU, DEU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEU-HF-FY-OI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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