ClinicalTrials.gg
RecruitingNCT05890625InT-mApUpdated Nov 21, 2023

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

An interventional study of On going treatment and InT-mAp in Infertility, Female, Web and Anxiety, sponsored by Maltepe University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-21.

Sponsored by Maltepe University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility, Female
  • Web
  • Anxiety
  • IVF

Keywords

  • infertility
  • web-based education
  • drug administration
  • treatment success
  • anxiety
03

In context

Infertility, Female

552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.

This study's planned enrollment of 74 is below the median of 100 across 378 interventional studies indexed under Infertility, Female.

Browse Infertility, Female studies →

Lead sponsor

Maltepe University is the lead sponsor of 67 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    InT-mAp

    Other: InT-mAp

  • Active comparator
    Control group

    Other: On going treatment

Interventions

  • OtherOn 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.

  • OtherInT-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: It will be administered before controlled ovarian hyperstimulation treatment and after embryo transfer. (At 0 and approx. at 12 weeks))

  2. Pregnancy rate

    Human chorionic gonadotropin (B-hCg)

    Time frame: 12 days after embryo transfer (approx. at 13 weeks)

  3. Treatment success

    Follicle count (Number of follicles formed after controlled ovarian hyperstimulation)

    Time frame: After controlled ovarian hyperstimulation treatment (at 4 weeks)

  4. Treatment success

    Oocyte count (Number of oocytes formed after controlled ovarian hyperstimulation)(

    Time frame: After controlled ovarian hyperstimulation treatment (at 4 weeks)

  5. Cycle success

    Embryo transfer rate (embryo transfer status)

    Time frame: After controlled ovarian hyperstimulation treatment (approx. at 12 weeks)

  6. 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.

    Time frame: before the treatment (at 0 week)

07

Study locations

1 of 1 sites recruiting
  • SBÜ Zeynep Kamil Kadın ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi
    Istanbul, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05890625
Lead sponsor
Maltepe University
Collaborators
Marmara University
Responsible party
Tuğba Bozdemir (Lecturer, Maltepe University) — Principal investigator
First posted
Jun 6, 2023
Start date
Jun 10, 2023
Primary completion
Dec 29, 2023 (estimated)
Completion
Feb 2024 (estimated)
Last update
Nov 21, 2023

Study contacts

Tugba Bozdemir
Contact
tugbabozdemir@maltepe.edu.tr
+90 5520978860
Hatice Yildiz
Contact
hatice.hy@gmail.com
+905323926429

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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