InfertilityUmayNCT07914491
Mobile Health Application for Fertility-Related Stress and Healthy Lifestyle in Women With Infertility
A study testing Printed Information Booklet and Umay Mobile Health Application in people with Infertility and Female Stress, run by Atlas University at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether a Turkish-language mobile health application (Umay) can reduce fertility-related stress and improve healthy lifestyle behaviours in women diagnosed with infertility who are receiving care at in vitro fertilisation clinics. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Infertility, Female Stress, Psychological
- What is being tested?
- Printed Information Booklet and Umay Mobile Health Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 16 Mar 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 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with infertility attending an in vitro fertilisation clinic
- Aged 21-45 years
- At least primary school education
- Owning an Android smartphone and able to use it
- Internet access
- Written informed consent
Who cannot join
- Participants were withdrawn if they asked to leave the study, did not open the application for seven consecutive days, had a long-term failure of the device used, or developed a serious health problem.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Medikalpark (Bahçelievler) Hospital
Istanbul, Istanbul, 34408
Medikalpark (Göztepe) Hospital
Istanbul, Istanbul, 34408
About this study
Official title: Development and Usability of a Mobile Health Application for People Diagnosed With Infertility to Manage Their Health: A Pilot Non-Randomized Controlled Trial
The goal of this clinical trial is to learn whether a Turkish-language mobile health application (Umay) can reduce fertility-related stress and improve healthy lifestyle behaviours in women diagnosed with infertility who are receiving care at in vitro fertilisation clinics.
The main questions it aims to answer are:
Read more
- Does using the Umay application for eight weeks lower fertility-related stress?
- Does using the application improve health-promoting lifestyle behaviours?
- Do women find the application easy to use and acceptable? Researchers compared the Umay application with a printed infertility information booklet containing the same information.
Participants:
- Used the Umay application (short videos on infertility and treatment, healthy lifestyle and stress management, a daily activity plan, yoga and meditation content, and three daily reminder notifications) or read the printed booklet, for eight weeks, alongside routine clinical care.
- Completed questionnaires on fertility-related stress (Fertility Problem Inventory) and lifestyle (Health-Promoting Lifestyle Profile II) at the start and after eight weeks.
- In the application group, also completed a usability questionnaire after eight weeks.
Read the detailed description
This was a pilot, non-randomised controlled trial with pre-test and post-test measurements, conducted between October 2023 and March 2024 in the in vitro fertilisation clinics of two branches of a private hospital in Istanbul, Türkiye.
The Umay application was developed in Turkish for women with infertility. It contains three modules (reproductive health and infertility, healthy lifestyle, and mental well-being) with 33 short videos, a daily plan in which users tick off recommended activities, fertility-oriented yoga videos, and a meditation section with relaxation music and a breathing exercise. Persuasive features, including daily push notifications (morning motivation, a daytime walking reminder and an evening sleep message) and a counter of days of use, were included to support engagement and behaviour change.
The control group received a 32-page printed booklet covering the same three topics. The booklet was reviewed by experts using the Suitability Assessment of Materials.
Eligible women were given a sequential number at enrolment and allocated alternately to the two groups (odd numbers to the application, even numbers to the booklet). Participants who withdrew were replaced, and 16 women per group completed the study. Within-group changes were analysed with the Wilcoxon signed-rank test.
The study was approved by the University of Health Sciences Hamidiye Scientific Research Ethics Committee (approval number 14097, 10 December 2022), and all participants gave written informed consent. The trial was registered retrospectively.
- Conditions
- Infertility, Female Stress, Psychological
- Being tested
- Printed Information Booklet, Umay Mobile Health Application
- Keywords
- mHealth, mobile application, fertility-related stress, health-promoting lifestyle, persuasive technology, usability, Türkiye
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Printed Information BookletBehavioural
Expert-reviewed printed booklet (32 pages) covering reproductive health and infertility, healthy lifestyle and mental well-being, given at baseline for use over eight weeks.
Umay Mobile Health ApplicationBehavioural
Smartphone application with three modules (reproductive health and infertility, healthy lifestyle, mental well-being) containing 33 short videos, a daily activity plan with check-boxes, fertility yoga videos, meditation music and a breathing exercise, and three daily push notifications (morning motivation, daytime walking reminder, evening sleep message). Used for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Umay Mobile Health Application | Experimental | Women used the Turkish-language Umay mobile health application for eight weeks in addition to routine clinical care. Receives: Behavioral: Umay Mobile Health Application |
| Printed Information Booklet | Active comparator | Women received a 32-page printed infertility information booklet with the same content to use for eight weeks in addition to routine clinical care. Receives: Behavioral: Printed Information Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility-related stress (Fertility Problem Inventory)
Measured with the Turkish version of the Fertility Problem Inventory (46 items; total and five subscales: social concern, sexual concern, relationship concern, need for parenthood, rejection of childfree lifestyle). Scores are reported as item means (range 1-6); higher scores indicate greater fertility-related stress.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
Health-promoting lifestyle (Health-Promoting Lifestyle Profile II)
Measured with the Turkish version of the Health-Promoting Lifestyle Profile II (52 items; total and six subscales: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management). Scores are reported as item means (range 1-4); higher scores indicate healthier lifestyle behaviours.
Measured: Baseline and 8 weeks
Usability of the mobile health application
Assessed in the intervention group only with an 11-item yes/no usability questionnaire and open-ended questions about the application.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Oct 2023
- Primary completion16 Mar 2024
- Study completion16 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups. Eligible women were given a sequential number at enrolment and allocated alternately: odd numbers to the Umay mobile health application group and even numbers to the printed information booklet group. Participants who withdrew were replaced until 16 women per group completed both assessments.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Done Kaplan, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914491
- Sponsor's protocol ID
- SBU-Hamidiye-14097
- Acronym
- Umay
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be deposited in a public repository. De-identified data are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Usability of a Mobile Health Application for People Diagnosed With Infertility to Manage Their Health: A Pilot Non-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07914491
- Acronym / sponsor ID
- Umay / SBU-Hamidiye-14097
- Conditions
- Infertility, Female Stress, Psychological
- Keywords
- mHealth, mobile application, fertility-related stress, health-promoting lifestyle, persuasive technology, usability, Türkiye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 16 Mar 2024 (actual)
- First posted
- 3 Nov 2026 (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.
The goal of this clinical trial is to learn whether a Turkish-language mobile health application (Umay) can reduce fertility-related stress and improve healthy lifestyle behaviours in women diagnosed with infertility who are receiving care at in vitro fertilisation clinics.
The main questions it aims to answer are:
- Does using the Umay application for eight weeks lower fertility-related stress?
- Does using the application improve health-promoting lifestyle behaviours?
- Do women find the application easy to use and acceptable? Researchers compared the Umay application with a printed infertility information booklet containing the same information.
Participants:
- Used the Umay application (short videos on infertility and treatment, healthy lifestyle and stress management, a daily activity plan, yoga and meditation content, and three daily reminder notifications) or read the printed booklet, for eight weeks, alongside routine clinical care.
- Completed questionnaires on fertility-related stress (Fertility Problem Inventory) and lifestyle (Health-Promoting Lifestyle Profile II) at the start and after eight weeks.
- In the application group, also completed a usability questionnaire after eight weeks.
Detailed description
This was a pilot, non-randomised controlled trial with pre-test and post-test measurements, conducted between October 2023 and March 2024 in the in vitro fertilisation clinics of two branches of a private hospital in Istanbul, Türkiye.
The Umay application was developed in Turkish for women with infertility. It contains three modules (reproductive health and infertility, healthy lifestyle, and mental well-being) with 33 short videos, a daily plan in which users tick off recommended activities, fertility-oriented yoga videos, and a meditation section with relaxation music and a breathing exercise. Persuasive features, including daily push notifications (morning motivation, a daytime walking reminder and an evening sleep message) and a counter of days of use, were included to support engagement and behaviour change.
The control group received a 32-page printed booklet covering the same three topics. The booklet was reviewed by experts using the Suitability Assessment of Materials.
Eligible women were given a sequential number at enrolment and allocated alternately to the two groups (odd numbers to the application, even numbers to the booklet). Participants who withdrew were replaced, and 16 women per group completed the study. Within-group changes were analysed with the Wilcoxon signed-rank test.
The study was approved by the University of Health Sciences Hamidiye Scientific Research Ethics Committee (approval number 14097, 10 December 2022), and all participants gave written informed consent. The trial was registered retrospectively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups. Eligible women were given a sequential number at enrolment and allocated alternately: odd numbers to the Umay mobile health application group and even numbers to the printed information booklet group. Participants who withdrew were replaced until 16 women per group completed both assessments.
| Arm | Type | Receives |
|---|---|---|
| Umay Mobile Health Application | Experimental | Behavioral: Umay Mobile Health ApplicationWomen used the Turkish-language Umay mobile health application for eight weeks in addition to routine clinical care. |
| Printed Information Booklet | Active comparator | Behavioral: Printed Information BookletWomen received a 32-page printed infertility information booklet with the same content to use for eight weeks in addition to routine clinical care. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women diagnosed with infertility attending an in vitro fertilisation clinic
- Aged 21-45 years
- At least primary school education
- Owning an Android smartphone and able to use it
- Internet access
Key exclusion criteria (1 listed)
- Participants were withdrawn if they asked to leave the study, did not open the application for seven consecutive days, had a long-term failure of the device used, or developed a serious health problem.
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 |
|---|---|---|
| Printed Information BookletExpert-reviewed printed booklet (32 pages) covering reproductive health and infertility, healthy lifestyle and mental well-being, given at baseline for use over eight weeks. | Behavioural | Printed Information Booklet |
| Umay Mobile Health ApplicationSmartphone application with three modules (reproductive health and infertility, healthy lifestyle, mental well-being) containing 33 short videos, a daily activity plan with check-boxes, fertility yoga videos, meditation music and a breathing exercise, and three daily push notifications (morning motivation, daytime walking reminder, evening sleep message). Used for eight weeks. | Behavioural | Umay Mobile Health Application |
Primary outcome
Fertility-related stress (Fertility Problem Inventory)
Time frame: Baseline and 8 weeks
Measured with the Turkish version of the Fertility Problem Inventory (46 items; total and five subscales: social concern, sexual concern, relationship concern, need for parenthood, rejection of childfree lifestyle). Scores are reported as item means (range 1-6); higher scores indicate greater fertility-related stress.
2 secondary outcomes
Health-promoting lifestyle (Health-Promoting Lifestyle Profile II)
Time frame: Baseline and 8 weeks
Usability of the mobile health application
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be deposited in a public repository. De-identified data are available from the corresponding author on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Printed Information Booklet and Umay Mobile Health Application in people with Infertility and Female Stress, run by Atlas University at 2 sites 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertility-related stress (Fertility Problem Inventory) (time frame: Baseline and 8 weeks). 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 3 Nov 2026.