Responsive Web-based Roadmap (InT-mAp) in Infertility Treatment (InT-mAp)

November 20, 2023 updated by: Tuğba Bozdemir, Maltepe University

The Effect of the Responsive Web-based Roadmap (InT-mAp) in Infertility Treatment on Women's Drug Administration, Treatment Success and Anxiety.

Infertility affects approximately 48 million couples and 186 million individuals globally, and it has biological, psychosocial, and economic problems in couples. It is a vital global reproductive health problem that has burdens and affects not only families but also society and the state.

Studies indicate that many situations experienced during the infertility treatment process negatively affect the treatment results, and the anxiety of individuals receiving treatment, especially women, is high. The previous literature reports that during the infertility treatment process, women experience a decrease in their anxiety and self-confidence about drug administration, they have doubts about the dose, administration, and time of drugs, and the rate of mistakes made regarding drug administration is too high to be ignored. Such cases may lead to cycle cancellations in infertility treatment, interrupting the treatment, adversely affecting the success of the treatment, and thus exposing the couple to more than one treatment trial. The interruption of the treatment with the cycle cancellation, the increase in the number of treatment attempts, the repetitions cause the woman to be exposed to a higher amount of drug, the cost to increase with each treatment trial, an increase in the economic burden of the couples, and an increase in the financial burden for the country. In addition to these physical and economic burdens, feelings such as anxiety, concern, hopelessness, and depression increase in couples, and they may eventually experience burnout.

In order to improve the care of infertile individuals, it is clearly stated in the literature that couples need open communication channels with health care professionals, obtaining qualified information, instilling realistic hope, empowerment, accessibility of care services, and they have unmet and high-quality care needs. The increase in the use and use of web-based education services in the globalizing world gives us hope in providing a solution to this issue.

This project was mainly designed to answer the question of "Is the responsive web-based roadmap (InT-mAp) developed in solving the problems encountered in drug administration, treatment success and reducing anxiety in infertile women treated with Assisted Reproductive Techniques (ART)?"

With InT-mAp, which investigators will develop using web-based education technology, which is a distance education method in this age of technology; investigators aimed to reduce/reduce the margin of error in ART treatment-drug practices, to contribute positively to the treatment process, and to reduce the social, economic and psychological burdens by reducing the anxiety level of individuals in this process. Besides, the InT-mAp, which will be developed to meet individuals' education and counseling needs for general infertility issues and the treatment process, will reduce the workload of healthcare professionals working in this field and make a positive contribution to drug administration consultancy.

With this study, investigators aimed to provide participants with time-saving, individualized care, to reach the right information whenever they want, regardless of time and place, on every subject they need in the field of infertility. Investigators predict that sufficient follicle development, healthy oocytes and pregnancy can be achieved by creating awareness in infertile women and minimizing the conditions that may adversely affect the treatment process and results. Contributing to the health and economic indicators of the country by reducing cycle cancellations and reducing costs are among our important goals. The most important features that make the project unique are the absence of online support and a sensitive web-based training platform, where the infertility treatment process in Turkey can be followed in detail by the users, and individualized care and training needs are met.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • 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 Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • SBÜ Zeynep Kamil Kadın ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi
        • Contact:

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • In vitro fertilization-Embryo transfer (IVF-ET)/ Intracytoplasmic Sperm Injection (ICSI)-ET treatment planned as assisted reproduction treatment (ART) and who are in the controlled ovarian hyperstimulation (COS) process of the treatment,
  • Having no psychological or chronic illness and related treatment that may affect the success of treatment other than the cause of infertility,
  • Primary infertile,
  • Being under 35 years old,
  • Able to speak, read and write Turkish, perceive and answer questions correctly and communicate effectively,
  • Having a smart phone with Android and the operating system for i-Phone (IOS) operating systems, being able to use mobile applications, and having sufficient equipment to use these applications (internet, etc.),
  • Women who volunteered to participate in the study will be included in the sample.

Exclusion Criteria:

  • Not meeting the sampling criteria,
  • Wanting to leave after the start of work,
  • Women with errors or deficiencies in their evaluation/use of the mobile application will be excluded from the study.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Other: On going treatment
No additional attempts will be made by the investigator on the cases in the control group. These cases will only benefit from the services in the clinic.
Experimental: InT-mAp
Other: InT-mAp
InT-mAp, the content of which will be created as a result of the evaluation of the nursing needs of infertile women, consists of a web-based training and online consultancy platform. The treatment plan specific to each participant will be entered into the web base individually, and the participants will be able to follow and manage the treatment protocols and appointments under their own control. InT-mAp is a guide that helps breakers about the intended use, effects, side effects of the drugs under treatment and how to self-administer, especially for women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Anxiety Level at 12 weeks
Time Frame: It will be administered before controlled ovarian hyperstimulation treatment and after embryo transfer. (At 0 and approx. at 12 weeks))
Beck Anxiety Inventory: The minimum score to be taken from the scale is 0, and the maximum score is 63.
It will be administered before controlled ovarian hyperstimulation treatment and after embryo transfer. (At 0 and approx. at 12 weeks))
Pregnancy rate
Time Frame: 12 days after embryo transfer (approx. at 13 weeks)
Human chorionic gonadotropin (B-hCg)
12 days after embryo transfer (approx. at 13 weeks)
Treatment success
Time Frame: After controlled ovarian hyperstimulation treatment (at 4 weeks)
Follicle count (Number of follicles formed after controlled ovarian hyperstimulation)
After controlled ovarian hyperstimulation treatment (at 4 weeks)
Treatment success
Time Frame: After controlled ovarian hyperstimulation treatment (at 4 weeks)
Oocyte count (Number of oocytes formed after controlled ovarian hyperstimulation)(
After controlled ovarian hyperstimulation treatment (at 4 weeks)
Cycle success
Time Frame: After controlled ovarian hyperstimulation treatment (approx. at 12 weeks)
Embryo transfer rate (embryo transfer status)
After controlled ovarian hyperstimulation treatment (approx. at 12 weeks)
Nursing Needs of Infertile Women
Time Frame: before the treatment (at 0 week)
Nursing Needs Assessment Scale For Women With Infertility: The lowest score that can be obtained from the scale is 18, and the highest score is 72.
before the treatment (at 0 week)

Collaborators and Investigators

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

Sponsor

Maltepe University

Collaborators

Marmara University

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 (Actual)

June 10, 2023

Primary Completion (Estimated)

December 29, 2023

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/20-02

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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