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CompletedNCT07914491UmayUpdated Nov 3, 2026

Mobile Health Application for Fertility-Related Stress and Healthy Lifestyle in Women With Infertility

An interventional study of Printed Information Booklet and Umay Mobile Health Application in Infertility, Female Stress and Psychological, sponsored by Atlas University. Completed at 2 sites in Turkey (Türkiye). Open to female participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

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

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Oct 2023, registered Oct 2026).
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
21 Years to 45 Years
Sex
Female
01

Study 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.

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.
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.

02

Conditions studied

  • Infertility
  • Female Stress
  • Psychological

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Keywords

  • mHealth
  • mobile application
  • fertility-related stress
  • health-promoting lifestyle
  • persuasive technology
  • usability
  • Türkiye
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 40 is below the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Atlas University is the lead sponsor of 96 studies on the registry; 25 are open to participants now.

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

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Umay Mobile Health Application

    Women used the Turkish-language Umay mobile health application for eight weeks in addition to routine clinical care.

    Behavioral: Umay Mobile Health Application

  • Active comparator
    Printed Information Booklet

    Women received a 32-page printed infertility information booklet with the same content to use for eight weeks in addition to routine clinical care.

    Behavioral: Printed Information Booklet

Interventions

  • BehavioralPrinted Information Booklet

    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.

  • BehavioralUmay Mobile Health Application

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 8 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and 8 weeks

  2. 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.

    Time frame: 8 weeks

07

Study locations

2 sites
  • Medikalpark (Bahçelievler) Hospital
    Istanbul, Istanbul 34408, Turkey (Türkiye)
  • Medikalpark (Göztepe) Hospital
    Istanbul, Istanbul 34408, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be deposited in a public repository. De-identified data are available from the corresponding author on reasonable request.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914491
Lead sponsor
Atlas University
Responsible party
Done Kaplan (Assistant Professor, Atlas University) — Principal investigator
First posted
Nov 3, 2026
Start date
Oct 1, 2023
Primary completion
Mar 16, 2024
Completion
Mar 16, 2024
Last update
Nov 3, 2026

Oversight

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

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