Online and Mobile Support Program and Fertility

NCT06824272 | Not Yet Recruiting

• 1 other identifier: DEU-HF-FY-OI
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief 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 fertility readiness, fertility self-efficacy, lifestyle, and pregnancy outcomes.

Conditions

Infertility; Stress

Keywords

Hypnofertility; Fertility Preparedness; Self-efficacy; Lifestyle; Pregnancy Outcome; Mobile Application; Online Education; infertility; pender

Outcome Measures

Primary Outcomes (1)

• pregnancy outcome

  The occurrence of clinical pregnancy after treatment will be evaluated.

  1 mounth

Secondary Outcomes (1)

• Fertility Readiness, Self-efficacy, Lifestyle

  6 mounth

Other Outcomes (2)

• Fertility Self Eficacy

  6 mounth

• Healthy Lifestyle Behaviors

  6 mounth

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

MOBIL AND ONLINE EDUCATION OTHER

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.

Intervention

Eligibility Criteria

• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• DEU

  DEU

  STUDY DIRECTOR

Central Study Contacts

Esra ARBAG Arbag

CONTACT

+905301471889; esmus.esra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Model Details: Our study includes an experimental group and a control group

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 13, 2025
• Study Start: March 30, 2025
• Primary Completion: August 12, 2025
• Study Completion: December 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share