Infertility, FemaleInT-mApNCT05890625
Responsive Web-based Roadmap (InT-mAp) in Infertility Treatment
A study testing On going treatment and InT-mAp in people with Infertility, Female and Web, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Web, Anxiety
- What is being tested?
- On going treatment and InT-mAp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SBÜ Zeynep Kamil Kadın ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi
Istanbul
Nazmiye y, (0216) 391 06 80, nazmiyey@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Infertility, Female, Web, Anxiety, IVF
- Being tested
- On going treatment, InT-mAp
- Keywords
- infertility, web-based education, drug administration, treatment success, anxiety
- Medical subject headings
- Infertility, Female, Anxiety Disorders, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On going treatmentOther
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.
InT-mApOther
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.
| Study group | Role | What they receive |
|---|---|---|
| InT-mAp | Experimental | Not described Receives: Other: InT-mAp |
| Control group | Active comparator | Not described Receives: Other: On going treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: It will be administered before controlled ovarian hyperstimulation treatment and after embryo transfer. (At 0 and approx. at 12 weeks))
Pregnancy rate
Human chorionic gonadotropin (B-hCg)
Measured: 12 days after embryo transfer (approx. at 13 weeks)
Treatment success
Follicle count (Number of follicles formed after controlled ovarian hyperstimulation)
Measured: After controlled ovarian hyperstimulation treatment (at 4 weeks)
Treatment success
Oocyte count (Number of oocytes formed after controlled ovarian hyperstimulation)(
Measured: After controlled ovarian hyperstimulation treatment (at 4 weeks)
Cycle success
Embryo transfer rate (embryo transfer status)
Measured: After controlled ovarian hyperstimulation treatment (approx. at 12 weeks)
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.
Measured: before the treatment (at 0 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start10 Jun 2023
- Primary completion29 Dec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Tuğba Bozdemir, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890625
- Sponsor's protocol ID
- 2022/20-02
- Acronym
- InT-mAp
- Status last verified
- Nov 2023
- First submitted
- 18 May 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Responsive Web-based Roadmap (InT-mAp) in Infertility Treatment on Women's Drug Administration, Treatment Success and Anxiety.
- ClinicalTrials.gov ID
- NCT05890625
- Acronym / sponsor ID
- InT-mAp / 2022/20-02
- Conditions
- Infertility, Female, Web, Anxiety, IVF
- Keywords
- infertility, web-based education, drug administration, treatment success, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InT-mAp | Experimental | Other: InT-mAp |
| Control group | Active comparator | Other: On going treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On going treatmentNo 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. | Other | Control group |
| InT-mApInT-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. | Other | InT-mAp |
Primary outcome
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.
Pregnancy rate
Time frame: 12 days after embryo transfer (approx. at 13 weeks)
Human chorionic gonadotropin (B-hCg)
Treatment success
Time frame: After controlled ovarian hyperstimulation treatment (at 4 weeks)
Follicle count (Number of follicles formed after controlled ovarian hyperstimulation)
Treatment success
Time frame: After controlled ovarian hyperstimulation treatment (at 4 weeks)
Oocyte count (Number of oocytes formed after controlled ovarian hyperstimulation)(
Cycle success
Time frame: After controlled ovarian hyperstimulation treatment (approx. at 12 weeks)
Embryo transfer rate (embryo transfer status)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On going treatment and InT-mAp in people with Infertility, Female and Web, run by Maltepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tugba Bozdemir (+90 5520978860, tugbabozdemir@maltepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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))). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.