NCT06960551

Brief Summary

The primary objective of this project is to increase the treatment compliance and success of infertile couples based on the Knowledge-Motivation-Behavioral Skills model. To develop a mobile web application and evaluate its effectiveness with scientific methods. The secondary aim was to evaluate the effect of using a mobile application on Infertility Affect Status, Self-Efficacy, Infertility Adjustment and State-Trait Anxiety. effect of the impact of the study.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

April 3, 2025

Last Update Submit

May 5, 2025

Conditions

Keywords

Obstetric NursingPrimary Care NursingInfertility, FemaleWeb Browser

Outcome Measures

Primary Outcomes (1)

  • Infertility Adjustment Scale

    The Turkish validity and reliability of the scale developed by Glover et al. was analyzed by Arslan Özkan et al. was conducted. The scale is six-point Likert-type and consists of 12 items. The scale is only administered to women. Scores that can be obtained from the scale are 12-72 ranges between the two scales. Increasing scores on the scale indicate an increase in maladjustment to loss of fertility. Cronbach's alpha coefficient was determined as 0.77

    three months

Secondary Outcomes (5)

  • Infertility Affect Scale

    three months

  • Participant Information Form

    three months

  • Infertility Self-Efficacy Scale-Short Form

    three months

  • State-Trait Anxiety Inventory

    three months

  • User Version of the Mobile Application Rating Scale

    three months

Study Arms (2)

ınfertilitech group

EXPERIMENTAL

Before starting the project, the couples in the experimental group will be informed about the mobile application. The women will use the mobile application weekly for 3 months. 4 times for at least 15 minutes each. To create motivation for use, women in the experimental group will be asked to motivational notification will be sent via the mobile application.

Other: ınfertility group

control group

OTHER

Women in the control group will not receive any intervention. After collecting the post-test data in the project, the principle of benefit and equality Taking this into account, women and their husbands participating in the control group will be given the opportunity to use the mobile application free of charge for three months.

Other: control group

Interventions

Before starting the project, the couples in the experimental group will be informed about the mobile application. The women will use the mobile application weekly for 3 months. 4 times for at least 15 minutes each. To create motivation for use, women in the experimental group will be asked to motivational notification will be sent via the mobile application.

ınfertilitech group

Women in the control group will not receive any intervention. After collecting the post-test data in the project, the principle of benefit and equality Taking this into account, women and their husbands participating in the control group will be given the opportunity to use the mobile application free of charge for three months.

control group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • for women;
  • To be between the ages of 18-45,
  • Being diagnosed with primary infertility,
  • To be able to read, write and understand Turkish,
  • Not having a disability to use a smartphone,
  • Being at the stage of agreeing to start infertility treatment (initial period of treatment),
  • Using the mobile app at least 4 times a week for 15 minutes each for 3 months for partner
  • Volunteer to participate in the project,
  • Not having a disability to use a smartphone,
  • Using the mobile app at least 1 time/15 minutes per week for 3 months

You may not qualify if:

  • for women
  • Incomplete answers to forms,
  • Not using the mobile app at all for a week,
  • Wanting to leave the study,
  • Voluntary discontinuation of infertility treatment for partner
  • Incomplete completion of the forms (uMARS and State-Trait Anxiety Inventory),
  • Not using the mobile app at all for two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InfertilityInfertility, Female

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Simge Öztürk, Ph.D

    Inonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simge Öztürk, Ph.D

CONTACT

sermin timur taşhan, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The project was planned as an experimental research with pretest-posttest experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

April 3, 2025

First Posted

May 7, 2025

Study Start

June 20, 2025

Primary Completion

September 20, 2025

Study Completion

September 20, 2025

Last Updated

May 7, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share