Female İnfertility
Conditions
Keywords
OPUCARE, Oocyte Pick-Up, Medication Adherence, State Anxiety, Assisted Reproductive Technology, Randomized Controlled Trial, Mobile Health Application, Fertility-Related Quality of Life
Brief summary
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.
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.
Interventions
BEHAVIORALOPUCARE
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.
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.
Sponsors
Istinye University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Because of the nature of the intervention, blinding of participants and study staff is not feasible.
Intervention model description
Participants will be assigned to one of two parallel groups: routine clinical care plus the OPUCARE system or routine clinical care and standard written and verbal information without mobile health application support.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in medication adherence score | Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline) | 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 the day before oocyte pick-up will be evaluated. |
| Change in fertility-related quality of life score | Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline) | 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 the day before oocyte pick-up will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in state anxiety score | Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline) | 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 the day before oocyte pick-up will be evaluated. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEmine Avcu, Lecturer, PhD student
PRINCIPAL_INVESTIGATOREmine Avcu, Lecturer, PhD student
Istinye University
Outcome results
None listed