Mobile Health Support Before Oocyte Pick-Up in Infertile Women
ConditionFemale İnfertility
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIstinye University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
OPUCARE
BehavioralOPUCARE 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
Other interventionRoutine 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Routine clinical care plus OPUCAREExperimental treatment 2 interventions
Group B: Routine clinical careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in medication adherence score
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.
Time frame
Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)2
Change in fertility-related quality of life score
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.
Time frame
Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)Secondary outcomes
1
Change in state anxiety score
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.
Time frame
Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)Other outcomes
1
Daily log-in frequency
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.
Time frame
From Day 1 through the day before oocyte pick-up (approximately 2 weeks)2
Module completion rate
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.
Time frame
From Day 1 through the day before oocyte pick-up (approximately 2 weeks)3
Medication confirmation percentage
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.
Time frame
From Day 1 through the day before oocyte pick-up (approximately 2 weeks)Sponsors and contacts
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Source ClinicalTrials.gov
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