search
Back to results

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

Primary Purpose

Infertility, Female, Web, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
On going treatment
InT-mAp
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility, Female focused on measuring infertility, web-based education, drug administration, treatment success, anxiety

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    InT-mAp

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change from Anxiety Level at 12 weeks
    Beck Anxiety Inventory: The minimum score to be taken from the scale is 0, and the maximum score is 63.
    Pregnancy rate
    Human chorionic gonadotropin (B-hCg)
    Treatment success
    Follicle count (Number of follicles formed after controlled ovarian hyperstimulation)
    Treatment success
    Oocyte count (Number of oocytes formed after controlled ovarian hyperstimulation)(
    Cycle success
    Embryo transfer rate (embryo transfer status)
    Nursing Needs of Infertile Women
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2023
    Last Updated
    June 5, 2023
    Sponsor
    Maltepe University
    Collaborators
    Marmara University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05890625
    Brief Title
    Responsive Web-based Roadmap (InT-mAp) in Infertility Treatment
    Acronym
    InT-mAp
    Official Title
    The Effect of the Responsive Web-based Roadmap (InT-mAp) in Infertility Treatment on Women's Drug Administration, Treatment Success and Anxiety.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maltepe University
    Collaborators
    Marmara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Female, Web, Anxiety, IVF
    Keywords
    infertility, web-based education, drug administration, treatment success, anxiety

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    74 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    InT-mAp
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    On going treatment
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    InT-mAp
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from Anxiety Level at 12 weeks
    Description
    Beck Anxiety Inventory: The minimum score to be taken from the scale is 0, and the maximum score is 63.
    Time Frame
    It will be administered before controlled ovarian hyperstimulation treatment and after embryo transfer. (At 0 and approx. at 12 weeks))
    Title
    Pregnancy rate
    Description
    Human chorionic gonadotropin (B-hCg)
    Time Frame
    12 days after embryo transfer (approx. at 13 weeks)
    Title
    Treatment success
    Description
    Follicle count (Number of follicles formed after controlled ovarian hyperstimulation)
    Time Frame
    After controlled ovarian hyperstimulation treatment (at 4 weeks)
    Title
    Treatment success
    Description
    Oocyte count (Number of oocytes formed after controlled ovarian hyperstimulation)(
    Time Frame
    After controlled ovarian hyperstimulation treatment (at 4 weeks)
    Title
    Cycle success
    Description
    Embryo transfer rate (embryo transfer status)
    Time Frame
    After controlled ovarian hyperstimulation treatment (approx. at 12 weeks)
    Title
    Nursing Needs of Infertile Women
    Description
    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.
    Time Frame
    before the treatment (at 0 week)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tugba Bozdemir
    Phone
    +90 5520978860
    Email
    tugbabozdemir@maltepe.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hatice Yildiz
    Phone
    +905323926429
    Email
    hatice.hy@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs