Mobile Health Support Before Oocyte Pick-Up in Infertile Women (OPUCARE)

July 7, 2026 updated by: Istinye University

Effect of a Structured Mobile Health Application on Medication Adherence and Quality of Life in Infertile Women Before Oocyte Pick-Up

This study aims to evaluate the effect of the OPUCARE system, a structured mobile health application used before oocyte pick-up (OPU), on medication adherence and quality of life in infertile women. The study will also examine the possible effect of the intervention on state anxiety.

Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive routine clinical care plus the OPUCARE system. The control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.

The intervention period will last approximately 2 weeks, from the start of medication treatment until oocyte pick-up. Medication adherence, quality of life, and state anxiety will be assessed before and after the intervention period.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is planned as a prospective, two-arm, randomized controlled trial to evaluate the clinical effectiveness of the OPUCARE system in infertile women during the period before oocyte pick-up (OPU). The study is based on a quantitative research approach and will use a pretest-posttest control group design.

The study population will consist of infertile women scheduled for OPU at a university hospital infertility clinic in Istanbul, Turkey. The sample size was determined by power analysis. According to the analysis performed using G*Power 3.1.9.7, at least 27 participants are required in each group. Considering possible attrition, 30 participants will be recruited for each group, for a total sample size of 60 participants.

Eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to the intervention group or the control group using a computer-generated randomization list prepared in advance. Because of the nature of the intervention, blinding of participants and implementers will not be possible. To reduce bias, data collection time points will be standardized, the same measurement tools will be applied to both groups in the same order, and analyses will be conducted according to a predefined statistical plan.

Participants in the intervention group will receive routine clinical care plus the OPUCARE system. Participants in the control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.

The OPUCARE system consists of two components: a patient-facing mobile support application and a clinic panel that allows healthcare professionals to monitor coded patient data. The patient application includes medication reminders, treatment process information, administration guidance, side effect management content, motivational messages, and an OPU countdown. The clinic panel enables secure monitoring of coded data such as medication adherence percentage, daily log-in frequency, module completion rates, and basic follow-up indicators.

The intervention period will last approximately 2 weeks, from the start of medication treatment until OPU. The primary outcomes of the study are medication adherence and fertility-related quality of life. State anxiety will be evaluated as a secondary psychosocial outcome. In addition, system usage indicators and user satisfaction with OPUCARE will be assessed in the intervention group.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female participants aged 18 years and older
  • Diagnosed with primary infertility
  • Scheduled to undergo oocyte pick-up (OPU) for the first time
  • Newly starting medication treatment during the period before OPU
  • Own a smartphone and are able to use basic mobile applications
  • Willing to participate in the study and provide written informed consent

Exclusion Criteria:

  • Diagnosis of secondary infertility
  • Presence of a serious chronic disease that may significantly affect medication adherence and/or quality of life
  • Presence of an active serious psychiatric disorder
  • Cognitive or physical limitation that prevents use of the mobile application

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Routine clinical care plus OPUCARE
Participants will receive routine clinical care and standard written and verbal information provided by the clinic, plus the OPUCARE system during the period before oocyte pick-up (OPU).
Behavioral: OPUCARE
OPUCARE is a structured mobile health support system consisting of a patient-facing mobile application and a clinic panel for coded patient monitoring. The patient application includes medication reminders, treatment process information, medication administration guidance, side effect management content, motivational messages, and an oocyte pick-up (OPU) countdown.
Other: Routine clinical care
Routine clinical care includes the standard counseling and written and verbal medication information routinely provided by the infertility clinic before oocyte pick-up (OPU). No mobile health application support will be provided as part of routine clinical care.
Active Comparator: Routine clinical care
Participants will receive routine clinical care and standard written and verbal information provided by the clinic during the period before oocyte pick-up (OPU), without mobile health application support.
Other: Routine clinical care
Routine clinical care includes the standard counseling and written and verbal medication information routinely provided by the infertility clinic before oocyte pick-up (OPU). No mobile health application support will be provided as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in medication adherence score
Time Frame: Baseline and day 14
Medication adherence will be assessed using the Medication Adherence Report Scale. The scale consists of 5 items scored on a 5-point Likert scale. Total scores range from 5 to 25, with higher scores indicating better medication adherence. The change in score between baseline and day 14 will be evaluated.
Baseline and day 14
Change in fertility-related quality of life score
Time Frame: Baseline and day 14
Fertility-related quality of life will be assessed using the Fertility Quality of Life Questionnaire. The questionnaire evaluates the impact of infertility and fertility treatment on quality of life. Scores are transformed to a 0 to 100 scale, with higher scores indicating better fertility-related quality of life. The change in score between baseline and day 14 will be evaluated.
Baseline and day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in state anxiety score
Time Frame: Baseline and day 14
State anxiety will be assessed using the State-Trait Anxiety Inventory-State form. The scale consists of 20 items scored on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating worse state anxiety. The change in score between baseline and day 14 will be evaluated.
Baseline and day 14

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily log-in frequency
Time Frame: Day 1 through day 14
Daily log-in frequency will be collected in the intervention group through OPUCARE system logs. The total number of participant log-ins recorded during the intervention period will be evaluated.
Day 1 through day 14
Module completion rate
Time Frame: Day 1 through day 14
Module completion rate will be collected in the intervention group through OPUCARE system logs. The percentage of completed educational and support modules during the intervention period will be evaluated.
Day 1 through day 14
Medication confirmation percentage
Time Frame: Day 1 through day 14
Medication confirmation percentage will be collected in the intervention group through OPUCARE system logs. The percentage of medication reminders confirmed by participants during the intervention period will be evaluated.
Day 1 through day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Investigators

  • Principal Investigator: Emine Avcu, Lecturer, PhD student, Istinye University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPUCARE-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study includes sensitive reproductive health-related data. All data will be coded and reported only in aggregate form to protect participant confidentiality and privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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